The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cisplatin or Carboplatin, and Etoposide With or Without Sunitinib Malate in Treating Patients With Extensive-Stage Small Cell Lung 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: NCT00453154
Recruitment Status : Completed
First Posted : March 28, 2007
Results First Posted : April 14, 2015
Last Update Posted : April 4, 2023
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Extensive Stage Lung Small Cell Carcinoma
Recurrent Lung Small Cell Carcinoma
Interventions Drug: Carboplatin
Drug: Cisplatin
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Other: Placebo Administration
Drug: Sunitinib Malate
Enrollment 156
Recruitment Details Between March 2007 and December 2011, 156 participants were recruited.
Pre-assignment Details  
Arm/Group Title Phase 1B Phase II Combination Chemotherapy Double Blind Placebo Maintenance With Optional Crossover Double Blind Sunitinib Maintenance
Hide Arm/Group Description

Participants will receive the following combination chemotherapy for 6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle

Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.

Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IVover 1 hour on days 1, 2, and 3 every cycle

Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.

At progression, participants receiving placebo could cross over to receive open label sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.

 Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
Period Title: Combination Chemotherapy
Started 12 144 0 0
Completed 12 95 0 0
Not Completed 0 49 0 0
Period Title: Double BIind Maintenance
Started 0 0 46 49
Completed 0 0 0 0
Not Completed 0 0 46 49
Reason Not Completed
Adverse Event             0             0             3             12
Death             0             0             2             1
Withdrawal by Subject             0             0             4             4
Progression             0             0             29             26
Medical Issues             0             0             3             1
Randomized, did not receive therapy             0             0             5             5
Period Title: Open Label Sunitinib Crossover
Started 0 0 18 0
Completed 0 0 18 0
Not Completed 0 0 0 0
Arm/Group Title Phase I Arm I (Combination Chemotherapy + Sunitinib Maintenance) Arm II (Combination Chemotherapy + Placebo Maintenance) Total
Hide Arm/Group Description

Participants will receive the following combination chemotherapy for 6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle

Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.

Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle

Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.

Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle

Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.

 Total of all reporting groups
Overall Number of Baseline Participants 12 44 41 97
Hide Baseline Analysis Population Description
Per protocol, participants who were randomized and received treatment were analyzed.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 44 participants 41 participants 97 participants
57
(43 to 72)
60
(39 to 69)
61
(56 to 77)
60
(39 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 44 participants 41 participants 97 participants
Female
4
  33.3%
26
  59.1%
21
  51.2%
51
  52.6%
Male
8
  66.7%
18
  40.9%
20
  48.8%
46
  47.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 44 participants 41 participants 97 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
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%
Black or African American
0
   0.0%
3
   6.8%
1
   2.4%
4
   4.1%
White
12
 100.0%
41
  93.2%
40
  97.6%
93
  95.9%
More than one race
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%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 44 participants 41 participants 97 participants
12 44 41 97
Chemotherapy Agent   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 12 participants 44 participants 41 participants 97 participants
Cisplatin NA [2]  12 11 NA [3] 
Carboplatin NA [2]  32 30 NA [3] 
[1]
Measure Description: Type of treatment received prior to maintenance randomization.
[2]
Stratification factor for Phase II, not collected for Phase I patients.
[3]
Total not calculated because data are not available (NA) in one or more arms.
Number of combination chemotherapy cycles   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 12 participants 44 participants 41 participants 97 participants
< 6 cycles NA [2]  12 9 NA [3] 
6 cycles NA [2]  32 32 NA [3] 
[1]
Measure Description: Number of cycles of combination chemotherapy received prior to maintenance randomization.
[2]
Stratification factor for Phase II, not collected for Phase I patients.
[3]
Total not calculated because data are not available (NA) in one or more arms.
1.Primary Outcome
Title Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)
Hide Description The maximum tolerated dose is defined at the highest sunitinib dose at which less than one third of participants develop a dose limiting toxicity (DLT). A DLT is defined as: delay of beginning cycle 2 of chemotherapy by > 7 days due to neutropenia, grade 4 hematologic toxicity lasting greater than 1 week (chemotherapy alone would be expected to cause significant grade 4 hematologic toxicity) or grade 3 or 4 nonhematologic toxicity (excluding grade 3 or 4 fatigue if the patient is found to be hypothyroid and responds to fatigue < grade 3 with thyroid replacement therapy).
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to safety concerns, the study committee discontinued sunitinib from combination chemotherapy to study single agent sunitinib in the maintenance setting.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3
Hide Arm/Group Description:

Participants will receive the following combination chemotherapy for 6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle

Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.

Participants will receive the following combination chemotherapy for 6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 37.5 mg oral, daily days 1-14 every cycle

Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.

Participants will receive the following combination chemotherapy for 6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 50 mg oral, daily days 1-14 every cycle

Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
Overall Number of Participants Analyzed 12 0 0
Measure Type: Number
Unit of Measure: mg/day
25
2.Primary Outcome
Title Progression-free Survival (Phase II)
Hide Description Progression free survival (PFS) was defined as the time from maintenance randomization to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized to maintenance were analyzed.
Arm/Group Title Arm I (Combination Chemotherapy + Sunitinib Maintenance) Arm II (Combination Chemotherapy + Placebo Maintenance)
Hide Arm/Group Description:

Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle

Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.

Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle

Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
Overall Number of Participants Analyzed 44 41
Median (95% Confidence Interval)
Unit of Measure: months
3.7
(1.8 to 4.3)
2.1
(1.6 to 2.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Combination Chemotherapy + Sunitinib Maintenance), Arm II (Combination Chemotherapy + Placebo Maintenance)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Using a 1-sided significance level of 0.15, the study has approximately 89% power to reject the null hypothesis
Statistical Test of Hypothesis P-Value 0.02
Comments All randomization was done using a permuted-block scheme with a block size of 6, stratified by combination chemotherapy (cisplatin vs carboplatin) and number of combination chemotherapy cycles (< 6 vs 6 cycles)
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.62
Confidence Interval (2-Sided) 70%
1.27 to 2.08
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized to maintenance were analyzed.
Arm/Group Title Arm I (Combination Chemotherapy + Sunitinib Maintenance) Arm II (Combination Chemotherapy + Placebo Maintenance)
Hide Arm/Group Description:

Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle

Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.

Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle

Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
Overall Number of Participants Analyzed 44 41
Median (95% Confidence Interval)
Unit of Measure: months
9.0
(8.0 to 12.7)
6.9
(5.4 to 11.8)
4.Secondary Outcome
Title Number of Participants With Overall Tumor Response
Hide Description Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized to maintenance were analyzed.
Arm/Group Title Arm I (Combination Chemotherapy + Sunitinib Maintenance) Arm II (Combination Chemotherapy + Placebo Maintenance)
Hide Arm/Group Description:

Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle

Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.

Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):

Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle

Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
Overall Number of Participants Analyzed 44 41
Measure Type: Number
Unit of Measure: participants
Complete Response 3 0
Partial Response 4 5
5.Other Pre-specified Outcome
Title Change in Plasma Levels of VEGF Prior to, During Single-agent, and Following Treatment With Sunitinib Malate
Hide Description The frequency of tumor response by the optimally dichotomized VEGF levels will be tabulated and their association will be tested by Fisher's exact test as well as the maximally selected rank test. The association of the VEGF levels as continuous predictor with tumor response will be tested by Wilcoxon rank sum test. Further assessments of the association of the VEGF levels as> continuous or binary variables and the tumor response will be implemented in a logistic regression while adjusting for other covariates such as performance status, weight loss and age
Time Frame Baseline to within 7 days of sunitinib/placebo therapy discontinuation
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Change in Plasma Levels of PDGF
Hide Description Correlated with clinical outcome (response and survival).
Time Frame Baseline to within 7 days of sunitinib/placebo therapy discontinuation
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description 84 participants were evaluable for adverse events.
 
Arm/Group Title Arm I (Combination Chemotherapy + Sunitinib Maintenance) Arm II (Combination Chemotherapy + Placebo Maintenance)
Hide Arm/Group Description Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression. Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
All-Cause Mortality
Arm I (Combination Chemotherapy + Sunitinib Maintenance) Arm II (Combination Chemotherapy + Placebo Maintenance)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm I (Combination Chemotherapy + Sunitinib Maintenance) Arm II (Combination Chemotherapy + Placebo Maintenance)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/43 (27.91%)      9/41 (21.95%)    
Blood and lymphatic system disorders     
Hemoglobin decreased † 1  5/43 (11.63%)  5 7/41 (17.07%)  7
Cardiac disorders     
Atrial fibrillation † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Cardiac disorder † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Supraventricular tachycardia † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Ear and labyrinth disorders     
Ear disorder † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Endocrine disorders     
Hypothyroidism † 1  0/43 (0.00%)  0 1/41 (2.44%)  3
Gastrointestinal disorders     
Abdominal distension † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Abdominal pain † 1  1/43 (2.33%)  1 1/41 (2.44%)  1
Colitis † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Constipation † 1  1/43 (2.33%)  1 2/41 (4.88%)  2
Diarrhea † 1  5/43 (11.63%)  6 3/41 (7.32%)  3
Dry mouth † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Dyspepsia † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Dysphagia † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Fecal incontinence † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Gastrointestinal disorder † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Nausea † 1  3/43 (6.98%)  3 2/41 (4.88%)  2
Pancreatic hemorrhage † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Pancreatitis † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Upper gastrointestinal hemorrhage † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Vomiting † 1  2/43 (4.65%)  2 0/41 (0.00%)  0
General disorders     
Chills † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Death NOS † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Disease progression † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Fatigue † 1  7/43 (16.28%)  8 5/41 (12.20%)  7
Fever † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Infections and infestations     
Appendicitis † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Pneumonia † 1  3/43 (6.98%)  3 1/41 (2.44%)  1
Investigations     
ADH abnormal † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Alanine aminotransferase increased † 1  4/43 (9.30%)  4 1/41 (2.44%)  1
Alkaline phosphatase increased † 1  5/43 (11.63%)  5 0/41 (0.00%)  0
Aspartate aminotransferase increased † 1  5/43 (11.63%)  5 1/41 (2.44%)  1
Blood bilirubin increased † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Creatinine increased † 1  2/43 (4.65%)  2 1/41 (2.44%)  1
Lipase increased † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Lymphocyte count decreased † 1  2/43 (4.65%)  2 2/41 (4.88%)  2
Neutrophil count decreased † 1  2/43 (4.65%)  2 0/41 (0.00%)  0
Platelet count decreased † 1  6/43 (13.95%)  6 1/41 (2.44%)  1
Weight loss † 1  1/43 (2.33%)  1 1/41 (2.44%)  1
Metabolism and nutrition disorders     
Anorexia † 1  2/43 (4.65%)  2 1/41 (2.44%)  1
Blood glucose increased † 1  6/43 (13.95%)  6 2/41 (4.88%)  2
Dehydration † 1  2/43 (4.65%)  2 1/41 (2.44%)  1
Serum albumin decreased † 1  2/43 (4.65%)  2 0/41 (0.00%)  0
Serum calcium decreased † 1  4/43 (9.30%)  4 1/41 (2.44%)  1
Serum calcium increased † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Serum glucose decreased † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Serum magnesium decreased † 1  2/43 (4.65%)  2 1/41 (2.44%)  1
Serum potassium decreased † 1  3/43 (6.98%)  3 0/41 (0.00%)  0
Serum sodium decreased † 1  5/43 (11.63%)  5 2/41 (4.88%)  2
Serum sodium increased † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Musculoskeletal and connective tissue disorders     
Back pain † 1  1/43 (2.33%)  1 1/41 (2.44%)  1
Bone pain † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Chest wall pain † 1  1/43 (2.33%)  1 2/41 (4.88%)  2
Neck pain † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Pain in extremity † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Nervous system disorders     
Ataxia † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Dizziness † 1  2/43 (4.65%)  2 1/41 (2.44%)  1
Headache † 1  1/43 (2.33%)  1 1/41 (2.44%)  1
Memory impairment † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Mini mental status examination abnormal † 1  1/43 (2.33%)  1 2/41 (4.88%)  2
Peripheral motor neuropathy † 1  2/43 (4.65%)  2 0/41 (0.00%)  0
Peripheral sensory neuropathy † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Seizure † 1  2/43 (4.65%)  2 0/41 (0.00%)  0
Syncope † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Psychiatric disorders     
Confusion † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Renal and urinary disorders     
Proteinuria † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchospasm † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Cough † 1  5/43 (11.63%)  5 2/41 (4.88%)  2
Dyspnea † 1  5/43 (11.63%)  5 5/41 (12.20%)  6
Hiccups † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Hypoxia † 1  2/43 (4.65%)  2 1/41 (2.44%)  2
Pleuritic pain † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Pneumonitis † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Respiratory disorder † 1  0/43 (0.00%)  0 2/41 (4.88%)  2
Respiratory tract hemorrhage † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia † 1  1/43 (2.33%)  1 1/41 (2.44%)  1
Dry skin † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Rash desquamating † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Skin hyperpigmentation † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Combination Chemotherapy + Sunitinib Maintenance) Arm II (Combination Chemotherapy + Placebo Maintenance)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/43 (95.35%)      38/41 (92.68%)    
Blood and lymphatic system disorders     
Hemoglobin decreased † 1  22/43 (51.16%)  59 28/41 (68.29%)  78
Thrombotic microangiopathy † 1  0/43 (0.00%)  0 1/41 (2.44%)  5
Cardiac disorders     
Palpitations † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Premature ventricular contractions † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Sinus tachycardia † 1  1/43 (2.33%)  1 1/41 (2.44%)  1
Ear and labyrinth disorders     
Ear disorder † 1  0/43 (0.00%)  0 3/41 (7.32%)  3
Ear pain † 1  1/43 (2.33%)  1 1/41 (2.44%)  1
Hearing impaired † 1  2/43 (4.65%)  2 3/41 (7.32%)  3
Middle ear inflammation † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Tinnitus † 1  1/43 (2.33%)  1 4/41 (9.76%)  5
Endocrine disorders     
Hyperthyroidism † 1  0/43 (0.00%)  0 1/41 (2.44%)  2
Hypothyroidism † 1  6/43 (13.95%)  18 2/41 (4.88%)  5
Eye disorders     
Diplopia † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Eye disorder † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Vision blurred † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Watering eyes † 1  2/43 (4.65%)  4 0/41 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension † 1  1/43 (2.33%)  3 0/41 (0.00%)  0
Abdominal pain † 1  2/43 (4.65%)  5 7/41 (17.07%)  8
Colitis † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Constipation † 1  7/43 (16.28%)  9 10/41 (24.39%)  13
Diarrhea † 1  21/43 (48.84%)  41 13/41 (31.71%)  24
Dry mouth † 1  3/43 (6.98%)  6 0/41 (0.00%)  0
Dyspepsia † 1  6/43 (13.95%)  6 3/41 (7.32%)  4
Dysphagia † 1  2/43 (4.65%)  3 1/41 (2.44%)  1
Ear, nose and throat examination abnormal † 1  8/43 (18.60%)  11 1/41 (2.44%)  2
Esophageal pain † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Flatulence † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Gastritis † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Gastrointestinal disorder † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Mouth necrosis † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Mucositis oral † 1  2/43 (4.65%)  3 1/41 (2.44%)  1
Nausea † 1  19/43 (44.19%)  34 20/41 (48.78%)  39
Oral hemorrhage † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Oral pain † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Pancreatitis † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Rectal hemorrhage † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Salivary gland disorder † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Toothache † 1  1/43 (2.33%)  4 0/41 (0.00%)  0
Vomiting † 1  5/43 (11.63%)  7 8/41 (19.51%)  13
General disorders     
Chest pain † 1  1/43 (2.33%)  1 2/41 (4.88%)  2
Chills † 1  4/43 (9.30%)  4 2/41 (4.88%)  4
Edema limbs † 1  0/43 (0.00%)  0 3/41 (7.32%)  3
Fatigue † 1  30/43 (69.77%)  91 31/41 (75.61%)  86
Fever † 1  3/43 (6.98%)  3 2/41 (4.88%)  3
Flu-like symptoms † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
General symptom † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Ill-defined disorder † 1  0/43 (0.00%)  0 1/41 (2.44%)  2
Localized edema † 1  1/43 (2.33%)  4 3/41 (7.32%)  3
Pain † 1  2/43 (4.65%)  2 0/41 (0.00%)  0
Infections and infestations     
Bladder infection † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Bronchitis † 1  1/43 (2.33%)  1 2/41 (4.88%)  2
Conjunctivitis infective † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Infection without neutropenia † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Pneumonia † 1  1/43 (2.33%)  1 2/41 (4.88%)  3
Sinusitis † 1  3/43 (6.98%)  8 2/41 (4.88%)  2
Tooth infection † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Upper aerodigestive tract infection † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Upper respiratory infection † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Urinary tract infection † 1  0/43 (0.00%)  0 1/41 (2.44%)  2
Injury, poisoning and procedural complications     
Dermatitis radiation † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Intraoperative respiratory injury - Trachea † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Thermal burn † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Investigations     
Alanine aminotransferase increased † 1  9/43 (20.93%)  19 6/41 (14.63%)  26
Alkaline phosphatase increased † 1  10/43 (23.26%)  14 5/41 (12.20%)  8
Amylase increased † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Aspartate aminotransferase increased † 1  8/43 (18.60%)  20 8/41 (19.51%)  16
Blood bilirubin increased † 1  1/43 (2.33%)  6 0/41 (0.00%)  0
Creatinine increased † 1  4/43 (9.30%)  19 2/41 (4.88%)  3
Growth hormone abnormal † 1  1/43 (2.33%)  2 0/41 (0.00%)  0
Leukocyte count decreased † 1  16/43 (37.21%)  35 8/41 (19.51%)  18
Lipase increased † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Lymphocyte count decreased † 1  8/43 (18.60%)  16 7/41 (17.07%)  13
Neutrophil count decreased † 1  13/43 (30.23%)  19 4/41 (9.76%)  6
Platelet count decreased † 1  19/43 (44.19%)  42 14/41 (34.15%)  33
Serum cholesterol increased † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Weight gain † 1  1/43 (2.33%)  1 2/41 (4.88%)  11
Weight loss † 1  3/43 (6.98%)  3 5/41 (12.20%)  5
Metabolism and nutrition disorders     
Anorexia † 1  12/43 (27.91%)  22 12/41 (29.27%)  18
Blood glucose increased † 1  16/43 (37.21%)  33 18/41 (43.90%)  42
Dehydration † 1  1/43 (2.33%)  1 1/41 (2.44%)  1
Serum albumin decreased † 1  6/43 (13.95%)  8 4/41 (9.76%)  4
Serum calcium decreased † 1  3/43 (6.98%)  4 1/41 (2.44%)  1
Serum calcium increased † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Serum glucose decreased † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Serum magnesium decreased † 1  2/43 (4.65%)  2 2/41 (4.88%)  2
Serum phosphate decreased † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Serum potassium decreased † 1  4/43 (9.30%)  5 4/41 (9.76%)  5
Serum potassium increased † 1  3/43 (6.98%)  8 2/41 (4.88%)  3
Serum sodium decreased † 1  7/43 (16.28%)  13 9/41 (21.95%)  14
Serum triglycerides increased † 1  0/43 (0.00%)  0 2/41 (4.88%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  8/43 (18.60%)  10 4/41 (9.76%)  7
Back pain † 1  6/43 (13.95%)  7 9/41 (21.95%)  16
Bone pain † 1  1/43 (2.33%)  1 2/41 (4.88%)  7
Chest wall pain † 1  1/43 (2.33%)  2 1/41 (2.44%)  1
Muscle weakness † 1  1/43 (2.33%)  1 2/41 (4.88%)  5
Muscle weakness lower limb † 1  0/43 (0.00%)  0 2/41 (4.88%)  2
Muscle weakness upper limb † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Musculoskeletal disorder † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Myalgia † 1  1/43 (2.33%)  1 5/41 (12.20%)  10
Neck pain † 1  1/43 (2.33%)  1 1/41 (2.44%)  1
Pain in extremity † 1  3/43 (6.98%)  5 4/41 (9.76%)  6
Nervous system disorders     
Abducens nerve disorder † 1  1/43 (2.33%)  2 0/41 (0.00%)  0
Dizziness † 1  6/43 (13.95%)  7 3/41 (7.32%)  4
Dysgeusia † 1  11/43 (25.58%)  18 4/41 (9.76%)  7
Headache † 1  6/43 (13.95%)  8 10/41 (24.39%)  13
IVth nerve disorder † 1  1/43 (2.33%)  2 0/41 (0.00%)  0
Memory impairment † 1  2/43 (4.65%)  2 0/41 (0.00%)  0
Mini mental status examination abnormal † 1  1/43 (2.33%)  1 1/41 (2.44%)  1
Neuralgia † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Neurological disorder NOS † 1  1/43 (2.33%)  1 3/41 (7.32%)  7
Oculomotor nerve disorder † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Olfactory nerve disorder † 1  0/43 (0.00%)  0 1/41 (2.44%)  9
Peripheral motor neuropathy † 1  3/43 (6.98%)  3 0/41 (0.00%)  0
Peripheral sensory neuropathy † 1  4/43 (9.30%)  13 6/41 (14.63%)  12
Seizure † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Tremor † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Psychiatric disorders     
Anxiety † 1  2/43 (4.65%)  2 2/41 (4.88%)  7
Depression † 1  1/43 (2.33%)  1 2/41 (4.88%)  5
Insomnia † 1  2/43 (4.65%)  4 7/41 (17.07%)  13
Libido decreased † 1  0/43 (0.00%)  0 1/41 (2.44%)  4
Renal and urinary disorders     
Glomerular filtration rate decreased † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Urinary frequency † 1  0/43 (0.00%)  0 2/41 (4.88%)  3
Urinary incontinence † 1  1/43 (2.33%)  3 1/41 (2.44%)  4
Reproductive system and breast disorders     
Breast pain † 1  0/43 (0.00%)  0 1/41 (2.44%)  2
Erectile dysfunction † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Vaginal discharge † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis † 1  1/43 (2.33%)  1 2/41 (4.88%)  6
Atelectasis † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Bronchopulmonary hemorrhage † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Bronchospasm † 1  0/43 (0.00%)  0 2/41 (4.88%)  2
Cough † 1  10/43 (23.26%)  17 17/41 (41.46%)  35
Dyspnea † 1  9/43 (20.93%)  29 12/41 (29.27%)  16
Epistaxis † 1  1/43 (2.33%)  1 1/41 (2.44%)  1
Nasal congestion † 1  1/43 (2.33%)  3 1/41 (2.44%)  1
Pharyngolaryngeal pain † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Pleural effusion † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Pleuritic pain † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Pneumonitis † 1  1/43 (2.33%)  4 0/41 (0.00%)  0
Respiratory disorder † 1  0/43 (0.00%)  0 3/41 (7.32%)  3
Respiratory tract hemorrhage † 1  5/43 (11.63%)  7 0/41 (0.00%)  0
Voice alteration † 1  1/43 (2.33%)  1 1/41 (2.44%)  1
Skin and subcutaneous tissue disorders     
Alopecia † 1  11/43 (25.58%)  20 13/41 (31.71%)  22
Dry skin † 1  3/43 (6.98%)  3 2/41 (4.88%)  2
Erythema multiforme † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Hand-and-foot syndrome † 1  5/43 (11.63%)  12 4/41 (9.76%)  7
Nail disorder † 1  1/43 (2.33%)  2 1/41 (2.44%)  1
Petechiae † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Pruritus † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Rash acneiform † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Rash desquamating † 1  3/43 (6.98%)  4 5/41 (12.20%)  5
Skin disorder † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Skin hyperpigmentation † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Skin hypopigmentation † 1  1/43 (2.33%)  1 0/41 (0.00%)  0
Sweating † 1  0/43 (0.00%)  0 3/41 (7.32%)  4
Vascular disorders     
Hot flashes † 1  0/43 (0.00%)  0 1/41 (2.44%)  1
Hypertension † 1  12/43 (27.91%)  23 7/41 (17.07%)  13
Hypotension † 1  2/43 (4.65%)  2 0/41 (0.00%)  0
Thrombosis † 1  2/43 (4.65%)  3 1/41 (2.44%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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. Neal Ready
Organization: Duke University Medical Center
EMail: ready001@mc.duke.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00453154    
Other Study ID Numbers: NCI-2009-00465
NCI-2009-00465 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000538229
CALGB 30504 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-30504 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: March 27, 2007
First Posted: March 28, 2007
Results First Submitted: March 24, 2015
Results First Posted: April 14, 2015
Last Update Posted: April 4, 2023