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A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01130519
Recruitment Status : Active, not recruiting
First Posted : May 26, 2010
Results First Posted : August 1, 2023
Last Update Posted : February 1, 2024
Sponsor:
Information provided by (Responsible Party):
Ramaprasad Srinivasan, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HLRCC
Sporadic Papillary Renal Cell Cancer
Interventions Drug: Bevacizumab
Drug: Erlotinib
Enrollment 83
Recruitment Details  
Pre-assignment Details  
Arm/Group Title COHORT 1-Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis and Renal Cell Cancer COHORT 2 - Sporadic Papillary Renal Cell Cancer COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer COHORT 4-Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer
Hide Arm/Group Description

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.
Period Title: Overall Study
Started 20 21 23 19
Completed 20 21 23 19
Not Completed 0 0 0 0
Arm/Group Title COHORT 1-Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis and Renal Cell Cancer COHORT 2 - Sporadic Papillary Renal Cell Cancer COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer COHORT 4-Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer Total
Hide Arm/Group Description

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.

 Total of all reporting groups
Overall Number of Baseline Participants 20 21 23 19 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 23 participants 19 participants 83 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
16
  76.2%
22
  95.7%
16
  84.2%
74
  89.2%
>=65 years
0
   0.0%
5
  23.8%
1
   4.3%
3
  15.8%
9
  10.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 23 participants 19 participants 83 participants
43.43  (12.15) 56.99  (9.61) 44.53  (12.98) 52.37  (13.98) 49.21  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 23 participants 19 participants 83 participants
Female
10
  50.0%
6
  28.6%
3
  13.0%
8
  42.1%
27
  32.5%
Male
10
  50.0%
15
  71.4%
20
  87.0%
11
  57.9%
56
  67.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 23 participants 19 participants 83 participants
Hispanic or Latino
1
   5.0%
1
   4.8%
1
   4.3%
0
   0.0%
3
   3.6%
Not Hispanic or Latino
19
  95.0%
20
  95.2%
22
  95.7%
19
 100.0%
80
  96.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 23 participants 19 participants 83 participants
American Indian or Alaska Native
1
   5.0%
0
   0.0%
2
   8.7%
1
   5.3%
4
   4.8%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  20.0%
0
   0.0%
1
   4.3%
3
  15.8%
8
   9.6%
White
15
  75.0%
21
 100.0%
20
  87.0%
15
  78.9%
71
  85.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 21 participants 23 participants 19 participants 83 participants
20 21 23 19 83
1.Primary Outcome
Title Overall Response Rate
Hide Description Participants whose tumors regressed (Complete Response (CR) plus Partial Response (PR)) after therapy as measured by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the longest diameters of target lesions. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Data shown with 95% confidence intervals.
Time Frame Every 8 weeks during the first 32 weeks and every 12 weeks thereafter, a median of 64.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 & 3) and all sporadic participants (Cohort 2 & 4).
Arm/Group Title COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer
Hide Arm/Group Description:

COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

COHORT 2 - Sporadic Papillary Renal Cell Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.

COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
72
(57 to 83)
35
(22 to 51)
2.Secondary Outcome
Title Progression-free Survival
Hide Description Median amount of time subject survives without disease progression after treatment. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
Time Frame Amount of time subject survives without disease progression after treatment; a median of 15 months.
Hide Outcome Measure Data
Hide Analysis Population Description
As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 & 3) and all sporadic participants (Cohort 2 & 4).
Arm/Group Title COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer
Hide Arm/Group Description:

COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

COHORT 2 - Sporadic Papillary Renal Cell Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.

COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.
Overall Number of Participants Analyzed 43 40
Median (95% Confidence Interval)
Unit of Measure: Months
21.1
(15.6 to 26.6)
8.9
(5.5 to 18.3)
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of overall response is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), measured by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
Time Frame Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented; a median of 19 months.
Hide Outcome Measure Data
Hide Analysis Population Description
As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 & 3) and all sporadic participants (Cohort 2 & 4).
Arm/Group Title COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer
Hide Arm/Group Description:

COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

COHORT 2 - Sporadic Papillary Renal Cell Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.

COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.
Overall Number of Participants Analyzed 43 40
Median (95% Confidence Interval)
Unit of Measure: Months
19.3
(12.9 to 35.9)
18.4
(13.8 to 49.7)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is defined as the duration of time from the date of study enrolment until time of death estimated using a Kaplan Meier analysis. Participants without a death event will be censored at the date survival assessment was last evaluated (e.g., clinic visit, phone call).
Time Frame Time from the date of study enrolment until time of death; a median of 29.3 months.
Hide Outcome Measure Data
Hide Analysis Population Description
As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 & 3) and all sporadic participants (Cohort 2 & 4).
Arm/Group Title COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer
Hide Arm/Group Description:

COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

COHORT 2 - Sporadic Papillary Renal Cell Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.

COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.
Overall Number of Participants Analyzed 43 40
Median (95% Confidence Interval)
Unit of Measure: Months
44.6 [1] 
(32.7 to NA)
18.2
(12.6 to 29.3)
[1]
Because the upper limit of the Kaplan-Meier curve for OS in the HLRCC cohorts hasn't reached 50%, there is no estimate for the upper confidence limit on the median. As such, we report the upper bound of the 95% CI as not estimable.
5.Other Pre-specified Outcome
Title Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Hide Description Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 & 3) and all sporadic participants (Cohort 2 & 4).
Arm/Group Title COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer
Hide Arm/Group Description:

COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

COHORT 2 - Sporadic Papillary Renal Cell Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.

COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.
Overall Number of Participants Analyzed 43 40
Measure Type: Count of Participants
Unit of Measure: Participants
43
 100.0%
40
 100.0%
Time Frame Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively.
Adverse Event Reporting Description As pre-specified by the protocol for safety/adverse events reporting purposes, expansion cohorts were combined with original cohorts (cohort 1-4). Thus, we reported on 2 groups: all Hereditary Leiomyomatosis and Renal Cell Cancer participants (Cohorts 1&3) and all sporadic participants (Cohort 2&4). Participants whose survival was obtained from other publicly available data sources/other National Institutes of Health protocols in which participants are co-enrolled are included in mortality.
 
Arm/Group Title COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer
Hide Arm/Group Description

COHORT 1 - Advanced Renal Cell Cancer Associated with Hereditary Leiomyomatosis and Renal Cell Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with metastatic Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC), diagnosed by either germline mutation of the fumarate hydratase (FH) gene, or based upon evidence of the clinical syndrome of HLRCC (characteristic renal cancer histology, cutaneous leiomyomas, uterine fibroids, and a family history).

COHORT 2 - Sporadic Papillary Renal Cell Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.

COHORT 4 - Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer

All participants will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO).

Participants with sporadic papillary renal cancer.
All-Cause Mortality
COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer
Affected / at Risk (%) Affected / at Risk (%)
Total   28/43 (65.12%)      36/40 (90.00%)    
Hide Serious Adverse Events
COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/43 (20.93%)      9/40 (22.50%)    
Cardiac disorders     
Acute coronary syndrome † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Cardiac arrest † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Myocardial infarction † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Eye disorders     
Blurred vision † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Diarrhea † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Duodenal stenosis † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Gastrointestinal pain † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Upper gastrointestinal hemorrhage † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Vomiting † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
General disorders     
Death NOS † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Fatigue † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Fever † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Multi-organ failure † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Investigations     
Alanine aminotransferase increased † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Creatinine increased † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Lipase increased † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Weight loss † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Metabolism and nutrition disorders     
Dehydration † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Hyperglycemia † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Hypoalbuminemia † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Hyponatremia † 1  0/43 (0.00%)  0 2/40 (5.00%)  2
Musculoskeletal and connective tissue disorders     
Flank pain † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Non-cardiac chest pain † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Nervous system disorders     
Dizziness † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Headache † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders - Other, Migraine headache † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Paresthesia † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Renal and urinary disorders     
Renal calculi † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchopulmonary hemorrhage † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Dyspnea † 1  1/43 (2.33%)  1 2/40 (5.00%)  3
Hypoxia † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders - Other, Hemoptysis † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Vascular disorders     
Hypertension † 1  0/43 (0.00%)  0 2/40 (5.00%)  2
Hypotension † 1  0/43 (0.00%)  0 4/40 (10.00%)  4
Thromboembolic event † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/43 (100.00%)      40/40 (100.00%)    
Blood and lymphatic system disorders     
Anemia † 1  14/43 (32.56%)  45 9/40 (22.50%)  13
Blood and lymphatic system disorders - Other, Iron deficiency † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Hemolysis † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Lymph node pain † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Cardiac disorders     
Atrial flutter † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Cardiac disorders - Other, Postural Hypotension † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Conduction disorder † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Palpitations † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Sinus bradycardia † 1  2/43 (4.65%)  2 1/40 (2.50%)  1
Sinus tachycardia † 1  3/43 (6.98%)  3 1/40 (2.50%)  1
Supraventricular tachycardia † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Ear and labyrinth disorders     
Ear and labyrinth disorders - Other, Clogged ear † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Ear pain † 1  2/43 (4.65%)  2 1/40 (2.50%)  1
Hearing impaired † 1  2/43 (4.65%)  2 0/40 (0.00%)  0
Middle ear inflammation † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Otitis media † 1  4/43 (9.30%)  6 0/40 (0.00%)  0
Tinnitus † 1  2/43 (4.65%)  2 0/40 (0.00%)  0
Vertigo † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Endocrine disorders     
Endocrine disorders - Other, Drenching night sweats † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Endocrine disorders - Other, Hypogonadism † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Hyperparathyroidism † 1  7/43 (16.28%)  8 5/40 (12.50%)  5
Hyperthyroidism † 1  2/43 (4.65%)  2 0/40 (0.00%)  0
Hypothyroidism † 1  11/43 (25.58%)  19 9/40 (22.50%)  13
Eye disorders     
Blurred vision † 1  3/43 (6.98%)  4 2/40 (5.00%)  2
Conjunctivitis † 1  3/43 (6.98%)  3 2/40 (5.00%)  2
Dry eye † 1  5/43 (11.63%)  6 5/40 (12.50%)  6
Eye disorders - Other, Blepharitis † 1  3/43 (6.98%)  4 1/40 (2.50%)  1
Eye disorders - Other, Eye Pressure R eye † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Eye disorders - Other, Eyelash growth † 1  3/43 (6.98%)  3 0/40 (0.00%)  0
Eye disorders - Other, Eyelid spasm † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Eye disorders - Other, L eye scleral hematoma † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Eye disorders - Other, Stye on L eye † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Eye disorders - Other, Styes in bilat upper eyelid † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Eye pain † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Floaters † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Keratitis † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Photophobia † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Retinal tear † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Uveitis † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Watering eyes † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal disorders     
Abdominal distension † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Abdominal pain † 1  15/43 (34.88%)  24 6/40 (15.00%)  10
Ascites † 1  1/43 (2.33%)  1 3/40 (7.50%)  3
Bloating † 1  4/43 (9.30%)  7 3/40 (7.50%)  3
Constipation † 1  8/43 (18.60%)  11 3/40 (7.50%)  3
Dental caries † 1  2/43 (4.65%)  2 1/40 (2.50%)  1
Diarrhea † 1  40/43 (93.02%)  112 34/40 (85.00%)  77
Dry mouth † 1  11/43 (25.58%)  11 2/40 (5.00%)  2
Duodenal stenosis † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Duodenal ulcer † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Dyspepsia † 1  5/43 (11.63%)  5 3/40 (7.50%)  3
Dysphagia † 1  1/43 (2.33%)  2 0/40 (0.00%)  0
Esophageal ulcer † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Fecal incontinence † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Flatulence † 1  4/43 (9.30%)  4 2/40 (5.00%)  2
Gastric ulcer † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Gastritis † 1  4/43 (9.30%)  10 1/40 (2.50%)  1
Gastroesophageal reflux disease † 1  20/43 (46.51%)  28 7/40 (17.50%)  9
Gastrointestinal disorders - Other, Abdominal cramping † 1  1/43 (2.33%)  2 0/40 (0.00%)  0
Gastrointestinal disorders - Other, Bone sequestrum † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal disorders - Other, Fractured tooth † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Gastrointestinal disorders - Other, R upper jaw bone spicule † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal disorders - Other, Stomach virus † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Gingival pain † 1  2/43 (4.65%)  3 0/40 (0.00%)  0
Hemorrhoidal hemorrhage † 1  3/43 (6.98%)  3 1/40 (2.50%)  1
Hemorrhoids † 1  9/43 (20.93%)  11 3/40 (7.50%)  3
Lower gastrointestinal hemorrhage † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Mucositis oral † 1  7/43 (16.28%)  13 4/40 (10.00%)  6
Nausea † 1  22/43 (51.16%)  27 20/40 (50.00%)  25
Oral dysesthesia † 1  5/43 (11.63%)  5 2/40 (5.00%)  2
Oral hemorrhage † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Oral pain † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Periodontal disease † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Rectal hemorrhage † 1  2/43 (4.65%)  2 1/40 (2.50%)  1
Sore throat † 1  9/43 (20.93%)  12 6/40 (15.00%)  6
Stomach pain † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Tooth discoloration † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Toothache † 1  4/43 (9.30%)  4 3/40 (7.50%)  3
Vomiting † 1  14/43 (32.56%)  20 10/40 (25.00%)  14
General disorders     
Chills † 1  3/43 (6.98%)  4 3/40 (7.50%)  3
Edema face † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Edema limbs † 1  6/43 (13.95%)  9 3/40 (7.50%)  4
Edema trunk † 1  4/43 (9.30%)  5 2/40 (5.00%)  2
Fatigue † 1  23/43 (53.49%)  60 25/40 (62.50%)  39
Fever † 1  2/43 (4.65%)  2 7/40 (17.50%)  7
Flu like symptoms † 1  9/43 (20.93%)  13 4/40 (10.00%)  4
General disorders and administration site conditions - Other, Canker sore † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
General disorders and administration site conditions - Other, Cold Intolerance † 1  0/43 (0.00%)  0 2/40 (5.00%)  2
General disorders and administration site conditions - Other, Foot cramps † 1  0/43 (0.00%)  0 1/40 (2.50%)  2
General disorders and administration site conditions - Other, tooth fracture † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Infusion related reaction † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Infusion site extravasation † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Irritability † 1  0/43 (0.00%)  0 1/40 (2.50%)  2
Localized edema † 1  2/43 (4.65%)  2 1/40 (2.50%)  1
Malaise † 1  2/43 (4.65%)  2 0/40 (0.00%)  0
Pain † 1  13/43 (30.23%)  35 11/40 (27.50%)  16
Immune system disorders     
Allergic reaction † 1  1/43 (2.33%)  2 3/40 (7.50%)  4
Infections and infestations     
Bladder infection † 1  2/43 (4.65%)  3 0/40 (0.00%)  0
Enterocolitis infectious † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Gum infection † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Infections and infestations - Other, Coronavirus † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Infections and infestations - Other, Ear abscess † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Infections and infestations - Other, Folliculitis R posterior thigh † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Infections and infestations - Other, Infection R arm @ biopsy suture site † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Infections and infestations - Other, Lyme Disease † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Infections and infestations - Other, Pre auricular abscess † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Infections and infestations - Other, SARS COVID 2 POSITIVE † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Infections and infestations - Other, Shingles † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Infections and infestations - Other, Viral gastroenteritis † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Joint infection † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Kidney infection † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Lung infection † 1  2/43 (4.65%)  3 0/40 (0.00%)  0
Nail infection † 1  1/43 (2.33%)  1 2/40 (5.00%)  2
Paronychia † 1  20/43 (46.51%)  49 7/40 (17.50%)  12
Pharyngitis † 1  0/43 (0.00%)  0 2/40 (5.00%)  2
Prostate infection † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Scrotal infection † 1  0/43 (0.00%)  0 2/40 (5.00%)  2
Sinusitis † 1  4/43 (9.30%)  6 7/40 (17.50%)  9
Skin infection † 1  12/43 (27.91%)  29 3/40 (7.50%)  6
Soft tissue infection † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Tooth infection † 1  3/43 (6.98%)  3 0/40 (0.00%)  0
Upper respiratory infection † 1  10/43 (23.26%)  12 9/40 (22.50%)  14
Urinary tract infection † 1  6/43 (13.95%)  13 3/40 (7.50%)  3
Vaginal infection † 1  3/43 (6.98%)  3 0/40 (0.00%)  0
Wound infection † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Injury, poisoning and procedural complications     
Bruising † 1  2/43 (4.65%)  2 0/40 (0.00%)  0
Burn † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Fall † 1  0/43 (0.00%)  0 3/40 (7.50%)  4
Injury, poisoning and procedural complications - Other, Laceration to L 3rd phalange † 1  1/43 (2.33%)  2 0/40 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged † 1  0/43 (0.00%)  0 2/40 (5.00%)  2
Alanine aminotransferase increased † 1  16/43 (37.21%)  46 18/40 (45.00%)  39
Alkaline phosphatase increased † 1  7/43 (16.28%)  20 17/40 (42.50%)  33
Aspartate aminotransferase increased † 1  22/43 (51.16%)  73 19/40 (47.50%)  56
Blood bilirubin increased † 1  11/43 (25.58%)  34 14/40 (35.00%)  59
CPK increased † 1  23/43 (53.49%)  117 10/40 (25.00%)  29
Creatinine increased † 1  31/43 (72.09%)  171 17/40 (42.50%)  79
Lipase increased † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Lymphocyte count decreased † 1  17/43 (39.53%)  40 19/40 (47.50%)  52
Lymphocyte count increased † 1  7/43 (16.28%)  21 3/40 (7.50%)  3
Neutrophil count decreased † 1  5/43 (11.63%)  10 2/40 (5.00%)  4
Platelet count decreased † 1  10/43 (23.26%)  28 9/40 (22.50%)  24
Serum amylase increased † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Weight gain † 1  9/43 (20.93%)  26 3/40 (7.50%)  9
Weight loss † 1  20/43 (46.51%)  78 14/40 (35.00%)  54
White blood cell decreased † 1  4/43 (9.30%)  8 4/40 (10.00%)  7
Metabolism and nutrition disorders     
Anorexia † 1  10/43 (23.26%)  17 14/40 (35.00%)  19
Dehydration † 1  2/43 (4.65%)  3 3/40 (7.50%)  4
Hypercalcemia † 1  13/43 (30.23%)  23 10/40 (25.00%)  22
Hyperglycemia † 1  13/43 (30.23%)  54 13/40 (32.50%)  40
Hyperkalemia † 1  20/43 (46.51%)  57 12/40 (30.00%)  37
Hypermagnesemia † 1  4/43 (9.30%)  16 6/40 (15.00%)  10
Hypernatremia † 1  3/43 (6.98%)  3 2/40 (5.00%)  2
Hypoalbuminemia † 1  22/43 (51.16%)  102 23/40 (57.50%)  85
Hypocalcemia † 1  10/43 (23.26%)  18 5/40 (12.50%)  12
Hypoglycemia † 1  22/43 (51.16%)  65 12/40 (30.00%)  27
Hypokalemia † 1  4/43 (9.30%)  7 2/40 (5.00%)  2
Hypomagnesemia † 1  15/43 (34.88%)  46 16/40 (40.00%)  38
Hyponatremia † 1  21/43 (48.84%)  97 19/40 (47.50%)  41
Hypophosphatemia † 1  22/43 (51.16%)  64 12/40 (30.00%)  27
Metabolism and nutrition disorders - Other, Night Sweats † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  9/43 (20.93%)  12 1/40 (2.50%)  1
Arthritis † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Back pain † 1  10/43 (23.26%)  11 8/40 (20.00%)  16
Bone pain † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Buttock pain † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Flank pain † 1  7/43 (16.28%)  9 4/40 (10.00%)  6
Generalized muscle weakness † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Joint effusion † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Joint range of motion decreased lumbar spine † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Muscle weakness lower limb † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, Achilles tendonitis L foot † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Ankle sprain † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, BLE cramp (intermittent) † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, BLE cramps at night † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, Back spasm † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Body aches/pain † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Costochondritis † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, Groin strain † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, Inguinal hernia † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Knee pain † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, L foot heaviness † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, LLE leg/calf muscle cramp † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Leg cramping † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, Leg cramping/stiffness of feet † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, Leg cramps † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Muscle aches † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Muscle cramps † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Muscle spasm, muscle cramps † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, Muscle spasm-bilat lower abd † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Plantar Fasciitis † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Rib Pain-L posterior † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorder - Other, Thigh spasms † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Myalgia † 1  9/43 (20.93%)  12 4/40 (10.00%)  4
Neck pain † 1  2/43 (4.65%)  2 0/40 (0.00%)  0
Non-cardiac chest pain † 1  7/43 (16.28%)  9 8/40 (20.00%)  9
Osteonecrosis of jaw † 1  3/43 (6.98%)  3 0/40 (0.00%)  0
Pain in extremity † 1  2/43 (4.65%)  3 6/40 (15.00%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain † 1  0/43 (0.00%)  0 1/40 (2.50%)  2
Nervous system disorders     
Akathisia † 1  2/43 (4.65%)  3 0/40 (0.00%)  0
Amnesia † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Cognitive disturbance † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Concentration impairment † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Dizziness † 1  9/43 (20.93%)  15 7/40 (17.50%)  11
Dysgeusia † 1  15/43 (34.88%)  19 15/40 (37.50%)  18
Dysphasia † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Headache † 1  7/43 (16.28%)  15 8/40 (20.00%)  14
Memory impairment † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Nervous system disorders - Other, Concussion † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Nervous system disorders - Other, Migraine headache † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Nervous system disorders - Other, Muscle twitches (intermittent) † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Nervous system disorders - Other, Tingling in bilateral hands/arms † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Nervous system disorders - Other, nerve pain at surgical scar † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Neuralgia † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Paresthesia † 1  5/43 (11.63%)  5 2/40 (5.00%)  2
Peripheral sensory neuropathy † 1  3/43 (6.98%)  5 2/40 (5.00%)  2
Spasticity † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Syncope † 1  1/43 (2.33%)  1 2/40 (5.00%)  2
Psychiatric disorders     
Anxiety † 1  4/43 (9.30%)  6 5/40 (12.50%)  6
Confusion † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Depression † 1  11/43 (25.58%)  14 3/40 (7.50%)  3
Insomnia † 1  10/43 (23.26%)  14 11/40 (27.50%)  13
Renal and urinary disorders     
Cystitis noninfective † 1  1/43 (2.33%)  1 2/40 (5.00%)  2
Hematuria † 1  26/43 (60.47%)  116 19/40 (47.50%)  69
Hemoglobinuria † 1  23/43 (53.49%)  91 22/40 (55.00%)  64
Hyperuricemia † 1  16/43 (37.21%)  63 5/40 (12.50%)  20
Proteinuria † 1  38/43 (88.37%)  357 28/40 (70.00%)  149
Renal and urinary disorders - Other, Asymptomatic bacteria † 1  1/43 (2.33%)  2 0/40 (0.00%)  0
Renal and urinary disorders - Other, Detrusor Sphincter Dyssynergia † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Renal and urinary disorders - Other, Dysuria † 1  2/43 (4.65%)  3 3/40 (7.50%)  4
Renal and urinary disorders - Other, Nocturia † 1  2/43 (4.65%)  2 0/40 (0.00%)  0
Renal and urinary disorders - Other, Urinary hesitancy † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Renal calculi † 1  2/43 (4.65%)  3 0/40 (0.00%)  0
Renal hemorrhage † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Urinary frequency † 1  3/43 (6.98%)  3 6/40 (15.00%)  6
Urinary incontinence † 1  2/43 (4.65%)  3 1/40 (2.50%)  1
Urinary retention † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Urinary tract pain † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Urinary urgency † 1  3/43 (6.98%)  3 1/40 (2.50%)  1
Urine discoloration † 1  16/43 (37.21%)  34 15/40 (37.50%)  27
Reproductive system and breast disorders     
Genital edema † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Irregular menstruation † 1  2/43 (4.65%)  2 0/40 (0.00%)  0
Libido decreased † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Menorrhagia † 1  1/43 (2.33%)  1 1/40 (2.50%)  2
Pelvic pain † 1  2/43 (4.65%)  2 0/40 (0.00%)  0
Reproductive system and breast disorders - Other, Hydrocele/scrotal swelling † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Reproductive system and breast disorders - Other, Labial sensitivity/soreness † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Reproductive system and breast disorders - Other, Vaginal spotting † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Scrotal pain † 1  0/43 (0.00%)  0 2/40 (5.00%)  2
Vaginal discharge † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Vaginal dryness † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis † 1  3/43 (6.98%)  3 4/40 (10.00%)  5
Bronchopulmonary hemorrhage † 1  0/43 (0.00%)  0 1/40 (2.50%)  2
Cough † 1  18/43 (41.86%)  30 20/40 (50.00%)  26
Dyspnea † 1  14/43 (32.56%)  17 4/40 (10.00%)  4
Epistaxis † 1  28/43 (65.12%)  43 12/40 (30.00%)  14
Hiccups † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Hoarseness † 1  5/43 (11.63%)  5 8/40 (20.00%)  9
Hypoxia † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Laryngeal inflammation † 1  0/43 (0.00%)  0 1/40 (2.50%)  2
Nasal congestion † 1  20/43 (46.51%)  34 11/40 (27.50%)  15
Pleural effusion † 1  2/43 (4.65%)  2 1/40 (2.50%)  1
Pleuritic pain † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Postnasal drip † 1  4/43 (9.30%)  4 3/40 (7.50%)  3
Productive cough † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Pulmonary hypertension † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders - Other, Congestion † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders - Other, Pneumonia † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders - Other, Post nasal drip † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, Runny nose † 1  1/43 (2.33%)  1 2/40 (5.00%)  2
Sinus disorder † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Sneezing † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Voice alteration † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Wheezing † 1  2/43 (4.65%)  2 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia † 1  16/43 (37.21%)  18 12/40 (30.00%)  12
Dry skin † 1  30/43 (69.77%)  32 23/40 (57.50%)  25
Hypertrichosis † 1  0/43 (0.00%)  0 2/40 (5.00%)  2
Nail discoloration † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Pain of skin † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Palmar-plantar erythrodysesthesia syndrome † 1  8/43 (18.60%)  14 2/40 (5.00%)  2
Papulopustular rash † 1  2/43 (4.65%)  2 0/40 (0.00%)  0
Photosensitivity † 1  5/43 (11.63%)  5 2/40 (5.00%)  3
Pruritus † 1  12/43 (27.91%)  15 9/40 (22.50%)  11
Rash acneiform † 1  42/43 (97.67%)  80 35/40 (87.50%)  54
Rash maculo-papular † 1  2/43 (4.65%)  3 1/40 (2.50%)  1
Scalp pain † 1  1/43 (2.33%)  2 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Abrasion R ear † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Abscess R axilla † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, Adhesive tape reaction † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Angular Cheilitis † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Basal cell ca. † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Bleeding gums † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, Blepharitis † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Brittle nails † 1  14/43 (32.56%)  15 5/40 (12.50%)  6
Skin and subcutaneous tissue disorders - Other, Chafing † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, Cold sore † 1  1/43 (2.33%)  2 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Dry sinus † 1  0/43 (0.00%)  0 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Erythema † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Erythema eyelids † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, Erythema flat rash L axilla/knee † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Erythematous painful groin rash † 1  1/43 (2.33%)  2 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Eczematous rash † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Exfoliative dermatitis † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Hair loss bilat hands † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Intermittent Mouth sores † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Intermittent tongue sores † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Inverse psoriasis of buttocks † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, Lip sore; lower lip † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, Lip ulcer/sore † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Melanotic macule buccal lesion R cheek † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Mouth blister/cold sore † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Mouth sore/swollen lip † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, Mouth sores † 1  4/43 (9.30%)  6 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Mouth sores-intermittent † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Mouth sores/bleeding gums/stomatitis † 1  0/43 (0.00%)  0 1/40 (2.50%)  2
Skin and subcutaneous tissue disorders - Other, Mucocutaneous disorder † 1  1/43 (2.33%)  4 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Night Sweats † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, Nose Sores † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Pain around fingernails † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Periorbital erythema rash † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, Poison Ivy † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Pruritis † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Psoriasiform hyperplasia † 1  0/43 (0.00%)  0 1/40 (2.50%)  2
Skin and subcutaneous tissue disorders - Other, R leg lesion † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Reddened and irritated umbilicus † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Sebaceous cyst † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Sensitivity & Tenderness under fingernails † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Sores on bottom of feet † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, Stye † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Sunburn † 1  1/43 (2.33%)  2 3/40 (7.50%)  3
Skin and subcutaneous tissue disorders - Other, Sunburn on face/upper torso † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Sweating † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, Throat sores † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Tick bite † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Tinea cruris † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Tinea corporis-breasts † 1  0/43 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, Tongue sores † 1  1/43 (2.33%)  2 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders - Other, mouth sores (intermittent) † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Skin hyperpigmentation † 1  1/43 (2.33%)  1 1/40 (2.50%)  1
Skin ulceration † 1  5/43 (11.63%)  6 0/40 (0.00%)  0
Urticaria † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Vascular disorders     
Flushing † 1  1/43 (2.33%)  1 2/40 (5.00%)  2
Hematoma † 1  2/43 (4.65%)  2 1/40 (2.50%)  1
Hot flashes † 1  2/43 (4.65%)  2 0/40 (0.00%)  0
Hypertension † 1  27/43 (62.79%)  49 15/40 (37.50%)  34
Hypotension † 1  2/43 (4.65%)  2 5/40 (12.50%)  6
Phlebitis † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
Thromboembolic event † 1  1/43 (2.33%)  1 0/40 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ramaprasad Srinivasan
Organization: National Cancer Institute
Phone: 240-760-6251
EMail: ramasrin@mail.nih.gov
Publications:
Layout table for additonal information
Responsible Party: Ramaprasad Srinivasan, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01130519    
Other Study ID Numbers: 100114
10-C-0114
First Submitted: May 25, 2010
First Posted: May 26, 2010
Results First Submitted: April 12, 2023
Results First Posted: August 1, 2023
Last Update Posted: February 1, 2024