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Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity 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: NCT01716715
Recruitment Status : Completed
First Posted : October 30, 2012
Results First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Interventions Drug: Cabozantinib S-malate
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Enrollment 111
Recruitment Details 111 patients were enrolled from November 6, 2012 to May 5, 2014
Pre-assignment Details  
Arm/Group Title Cabozantinib Paclitaxel
Hide Arm/Group Description Cabozantinib 60 mg oral daily continously Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Period Title: Overall Study
Started 57 54
Completed 55 50
Not Completed 2 4
Reason Not Completed
Never Treated             2             4
Arm/Group Title Cabozantinib Paclitaxel Total
Hide Arm/Group Description Cabozantinib 60 mg oral daily continously Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15 Total of all reporting groups
Overall Number of Baseline Participants 57 54 111
Hide Baseline Analysis Population Description
Enrolled participants
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 57 participants 54 participants 111 participants
20-29 years
0
   0.0%
0
   0.0%
0
   0.0%
30-39 years
1
   1.8%
1
   1.9%
2
   1.8%
40-49 years
5
   8.8%
4
   7.4%
9
   8.1%
50-59 years
21
  36.8%
19
  35.2%
40
  36.0%
60-69 years
20
  35.1%
24
  44.4%
44
  39.6%
70-79 years
9
  15.8%
6
  11.1%
15
  13.5%
>=80 years
1
   1.8%
0
   0.0%
1
   0.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 54 participants 111 participants
Female
57
 100.0%
54
 100.0%
111
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 54 participants 111 participants
American Indian or Alaska Native
0
   0.0%
1
   1.9%
1
   0.9%
Asian
1
   1.8%
3
   5.6%
4
   3.6%
Native Hawaiian or Other Pacific Islander
1
   1.8%
0
   0.0%
1
   0.9%
Black or African American
4
   7.0%
2
   3.7%
6
   5.4%
White
50
  87.7%
48
  88.9%
98
  88.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.8%
0
   0.0%
1
   0.9%
1.Primary Outcome
Title Event Free Survival
Hide Description Time from patient entry until progression, death, or beginning a subsequent therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
Time Frame The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Patients
Arm/Group Title Cabozantinib Paclitaxel
Hide Arm/Group Description:
Cabozantinib 60 mg oral daily continously
Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Overall Number of Participants Analyzed 57 54
Median (95% Confidence Interval)
Unit of Measure: months
3.48
(2.79 to 4.07)
4.96
(3.71 to 5.72)
2.Secondary Outcome
Title Number of Participants With Grade 3 or Higher Adverse Events by Type
Hide Description Toxicities will be characterized by their frequency and severity, grade 3 and above.
Time Frame Up to 30 days after completion of study treatment
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Hide Analysis Population Description
Eligible and Treated participants
Arm/Group Title Grade 3 and Above on Cabozantinib Grade 3 and Above on Paclitaxel
Hide Arm/Group Description:
Grade 3 and above toxicities for participants on Cabozantinib 60 mg oral daily continously
Grade 3 toxicities for participants on Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Overall Number of Participants Analyzed 55 50
Measure Type: Count of Participants
Unit of Measure: Participants
Neutropenia
2
   3.6%
4
   8.0%
Anemia
4
   7.3%
0
   0.0%
Gastrointestinal
15
  27.3%
2
   4.0%
Metabolism/nutrition
10
  18.2%
3
   6.0%
Musculoskeletal/connective tissue
1
   1.8%
0
   0.0%
Nervous System
3
   5.5%
0
   0.0%
Renal/Urinary
1
   1.8%
0
   0.0%
Respiratory/thoracic/mediastinal
3
   5.5%
1
   2.0%
Skin/subcutaneous
2
   3.6%
0
   0.0%
Vascular disorders
12
  21.8%
5
  10.0%
3.Secondary Outcome
Title Response, Assessed According to RECIST Version 1.1
Hide Description Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame CT or MRI used to follow lesion every 8 weeks for the first 8 months, then every 12 weeks until disease progression, approximately 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Cabozantinib Paclitaxel
Hide Arm/Group Description:
Cabozantinib 60 mg oral daily continously
Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Overall Number of Participants Analyzed 57 54
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
7.02
(2.4 to 15.3)
24.07
(14.9 to 35.5)
4.Secondary Outcome
Title Percentage of Participants With CA125 Response.
Hide Description Complete and Partial Tumor Response by CA125. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
Time Frame Prior to each cycle of treatment. Then follow-up every 3 months for 2 years then then every 6 months, up to 2.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants evaluable by CA125
Arm/Group Title Cabozantinib Paclitaxel
Hide Arm/Group Description:
Cabozantinib 60 mg oral daily continously
Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Overall Number of Participants Analyzed 34 29
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
29.4
(16.9 to 44.8)
58.6
(41.7 to 74.1)
5.Secondary Outcome
Title Overall Survival
Hide Description The time from randomization until death or date of last contact. Endpoint is death. Patients who are not observed with an endpoint are censored.
Time Frame The duration of time from study entry to time of death or the date of last contact, an average of 2.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Cabozantinib Paclitaxel
Hide Arm/Group Description:
Cabozantinib 60 mg oral daily continously
Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Overall Number of Participants Analyzed 57 54
Median (90% Confidence Interval)
Unit of Measure: months
19.4 [1] 
(12.3 to NA)
NA [2] 
(16 to NA)
[1]
Upper limit of confidence interval has not been reached
[2]
The median and upper limit of confidence interval has not been reached
6.Secondary Outcome
Title To Estimate the Response Duration Among Patients Who Respond.
Hide Description The time participant is in response.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
Time Frame From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented or date of death from any cause, whichever came first, assessed up to 18 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who respond.
Arm/Group Title Cabozantinib Paclitaxel
Hide Arm/Group Description:
Cabozantinib 60 mg oral daily continously
Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Overall Number of Participants Analyzed 4 13
Median (Full Range)
Unit of Measure: months
3.8
(0.1 to 4.3)
7.4
(3.5 to 16.7)
7.Other Pre-specified Outcome
Title c-Met Expression
Hide Description [Not Specified]
Time Frame Baseline
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title c-MET Copy Number
Hide Description [Not Specified]
Time Frame Baseline
Outcome Measure Data Not Reported
Time Frame During study treatment through 30 days after treatment ends, an average of 2.5 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cabozantinib Paclitaxel
Hide Arm/Group Description Cabozantinib 60 mg oral daily continously Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
All-Cause Mortality
Cabozantinib Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cabozantinib Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   25/55 (45.45%)   8/50 (16.00%) 
Gastrointestinal disorders     
Diarrhea * 1  1/55 (1.82%)  0/50 (0.00%) 
Small Intestinal Perforation * 1  1/55 (1.82%)  0/50 (0.00%) 
Small Intestinal Obstruction * 1  2/55 (3.64%)  0/50 (0.00%) 
Abdominal Pain * 1  1/55 (1.82%)  2/50 (4.00%) 
Mucositis Oral * 1  1/55 (1.82%)  0/50 (0.00%) 
Anal Pain * 1  2/55 (3.64%)  0/50 (0.00%) 
Ileal Obstruction * 1  1/55 (1.82%)  0/50 (0.00%) 
General disorders     
Pain * 1  1/55 (1.82%)  0/50 (0.00%) 
Fever * 1  0/55 (0.00%)  2/50 (4.00%) 
Injury, poisoning and procedural complications     
Wound Complication * 1  2/55 (3.64%)  0/50 (0.00%) 
Investigations     
Lipase Increased * 1  2/55 (3.64%)  0/50 (0.00%) 
Aspartate Aminotransferase Increased * 1  1/55 (1.82%)  0/50 (0.00%) 
Alanine Aminotransferase Increased * 1  2/55 (3.64%)  0/50 (0.00%) 
Metabolism and nutrition disorders     
Hyponatremia * 1  1/55 (1.82%)  0/50 (0.00%) 
Hypomagnesemia * 1  2/55 (3.64%)  0/50 (0.00%) 
Hypokalemia * 1  0/55 (0.00%)  1/50 (2.00%) 
Hyperkalemia * 1  1/55 (1.82%)  0/50 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms Benign, Malignant And Unspecified (Incl * 1  1/55 (1.82%)  0/50 (0.00%) 
Nervous system disorders     
Memory Impairment * 1  1/55 (1.82%)  0/50 (0.00%) 
Dizziness * 1  1/55 (1.82%)  0/50 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Hypertension * 1  1/55 (1.82%)  0/50 (0.00%) 
Pleural Effusion * 1  1/55 (1.82%)  1/50 (2.00%) 
Dyspnea * 1  1/55 (1.82%)  0/50 (0.00%) 
Skin and subcutaneous tissue disorders     
Palmar-Plantar Erythrodysesthesia Syndrome * 1  1/55 (1.82%)  0/50 (0.00%) 
Vascular disorders     
Thromboembolic Event * 1  4/55 (7.27%)  2/50 (4.00%) 
Hypertension * 1  2/55 (3.64%)  0/50 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cabozantinib Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   55/55 (100.00%)   50/50 (100.00%) 
Blood and lymphatic system disorders     
Anemia * 1  23/55 (41.82%)  46/50 (92.00%) 
Cardiac disorders     
Sinus Bradycardia * 1  1/55 (1.82%)  1/50 (2.00%) 
Palpitations * 1  2/55 (3.64%)  0/50 (0.00%) 
Atrioventricular Block First Degree * 1  1/55 (1.82%)  0/50 (0.00%) 
Cardiac Disorders - Other * 1  1/55 (1.82%)  0/50 (0.00%) 
Ventricular Arrhythmia * 1  1/55 (1.82%)  0/50 (0.00%) 
Ear and labyrinth disorders     
Tinnitus * 1  4/55 (7.27%)  3/50 (6.00%) 
Ear Pain * 1  3/55 (5.45%)  1/50 (2.00%) 
Endocrine disorders     
Hypothyroidism * 1  12/55 (21.82%)  0/50 (0.00%) 
Hyperthyroidism * 1  7/55 (12.73%)  1/50 (2.00%) 
Endocrine Disorders - Other * 1  1/55 (1.82%)  0/50 (0.00%) 
Eye disorders     
Watering Eyes * 1  0/55 (0.00%)  1/50 (2.00%) 
Conjunctivitis * 1  0/55 (0.00%)  2/50 (4.00%) 
Blurred Vision * 1  3/55 (5.45%)  5/50 (10.00%) 
Dry Eye * 1  0/55 (0.00%)  1/50 (2.00%) 
Eyelid Function Disorder * 1  0/55 (0.00%)  1/50 (2.00%) 
Gastrointestinal disorders     
Dysphagia * 1  1/55 (1.82%)  1/50 (2.00%) 
Dyspepsia * 1  7/55 (12.73%)  1/50 (2.00%) 
Dry Mouth * 1  10/55 (18.18%)  0/50 (0.00%) 
Colitis * 1  1/55 (1.82%)  1/50 (2.00%) 
Constipation * 1  16/55 (29.09%)  14/50 (28.00%) 
Enterovesical Fistula * 1  0/55 (0.00%)  1/50 (2.00%) 
Diarrhea * 1  37/55 (67.27%)  19/50 (38.00%) 
Vomiting * 1  20/55 (36.36%)  5/50 (10.00%) 
Bloating * 1  6/55 (10.91%)  1/50 (2.00%) 
Abdominal Pain * 1  21/55 (38.18%)  13/50 (26.00%) 
Rectal Hemorrhage * 1  4/55 (7.27%)  4/50 (8.00%) 
Oral Dysesthesia * 1  2/55 (3.64%)  0/50 (0.00%) 
Obstruction Gastric * 1  1/55 (1.82%)  0/50 (0.00%) 
Mucositis Oral * 1  21/55 (38.18%)  6/50 (12.00%) 
Lower Gastrointestinal Hemorrhage * 1  1/55 (1.82%)  0/50 (0.00%) 
Gastrointestinal Disorders - Other * 1  1/55 (1.82%)  0/50 (0.00%) 
Gastrointestinal Pain * 1  1/55 (1.82%)  1/50 (2.00%) 
Oral Pain * 1  3/55 (5.45%)  0/50 (0.00%) 
Abdominal Distension * 1  4/55 (7.27%)  3/50 (6.00%) 
Nausea * 1  34/55 (61.82%)  23/50 (46.00%) 
Gastroesophageal Reflux Disease * 1  6/55 (10.91%)  0/50 (0.00%) 
Rectal Pain * 1  1/55 (1.82%)  1/50 (2.00%) 
Esophagitis * 1  1/55 (1.82%)  0/50 (0.00%) 
Fecal Incontinence * 1  1/55 (1.82%)  0/50 (0.00%) 
Hemorrhoids * 1  1/55 (1.82%)  1/50 (2.00%) 
Ascites * 1  6/55 (10.91%)  3/50 (6.00%) 
Toothache * 1  1/55 (1.82%)  0/50 (0.00%) 
Esophageal Pain * 1  1/55 (1.82%)  0/50 (0.00%) 
Flatulence * 1  3/55 (5.45%)  1/50 (2.00%) 
General disorders     
Pain * 1  8/55 (14.55%)  7/50 (14.00%) 
Localized Edema * 1  2/55 (3.64%)  1/50 (2.00%) 
Irritability * 1  0/55 (0.00%)  1/50 (2.00%) 
Injection Site Reaction * 1  0/55 (0.00%)  1/50 (2.00%) 
Flu Like Symptoms * 1  0/55 (0.00%)  1/50 (2.00%) 
Edema Trunk * 1  1/55 (1.82%)  0/50 (0.00%) 
Non-Cardiac Chest Pain * 1  3/55 (5.45%)  0/50 (0.00%) 
Edema Limbs * 1  6/55 (10.91%)  9/50 (18.00%) 
Fatigue * 1  43/55 (78.18%)  35/50 (70.00%) 
Fever * 1  3/55 (5.45%)  5/50 (10.00%) 
Gait Disturbance * 1  0/55 (0.00%)  1/50 (2.00%) 
Chills * 1  2/55 (3.64%)  0/50 (0.00%) 
Immune system disorders     
Allergic Reaction * 1  0/55 (0.00%)  1/50 (2.00%) 
Infections and infestations     
Wound Infection * 1  1/55 (1.82%)  0/50 (0.00%) 
Upper Respiratory Infection * 1  1/55 (1.82%)  4/50 (8.00%) 
Tooth Infection * 1  1/55 (1.82%)  1/50 (2.00%) 
Stoma Site Infection * 1  1/55 (1.82%)  0/50 (0.00%) 
Skin Infection * 1  1/55 (1.82%)  0/50 (0.00%) 
Rhinitis Infective * 1  1/55 (1.82%)  0/50 (0.00%) 
Pharyngitis * 1  0/55 (0.00%)  1/50 (2.00%) 
Otitis Media * 1  0/55 (0.00%)  1/50 (2.00%) 
Papulopustular Rash * 1  1/55 (1.82%)  1/50 (2.00%) 
Mucosal Infection * 1  2/55 (3.64%)  0/50 (0.00%) 
Esophageal Infection * 1  1/55 (1.82%)  0/50 (0.00%) 
Urinary Tract Infection * 1  3/55 (5.45%)  1/50 (2.00%) 
Catheter Related Infection * 1  0/55 (0.00%)  1/50 (2.00%) 
Enterocolitis Infectious * 1  0/55 (0.00%)  1/50 (2.00%) 
Bladder Infection * 1  1/55 (1.82%)  0/50 (0.00%) 
Anorectal Infection * 1  1/55 (1.82%)  0/50 (0.00%) 
Injury, poisoning and procedural complications     
Hip Fracture * 1  1/55 (1.82%)  0/50 (0.00%) 
Fracture * 1  1/55 (1.82%)  0/50 (0.00%) 
Fall * 1  1/55 (1.82%)  1/50 (2.00%) 
Burn * 1  0/55 (0.00%)  1/50 (2.00%) 
Bruising * 1  1/55 (1.82%)  3/50 (6.00%) 
Investigations     
Weight Loss * 1  9/55 (16.36%)  2/50 (4.00%) 
Weight Gain * 1  0/55 (0.00%)  2/50 (4.00%) 
Serum Amylase Increased * 1  7/55 (12.73%)  3/50 (6.00%) 
Platelet Count Decreased * 1  28/55 (50.91%)  6/50 (12.00%) 
Lymphocyte Count Decreased * 1  1/55 (1.82%)  4/50 (8.00%) 
Lipase Increased * 1  11/55 (20.00%)  0/50 (0.00%) 
Inr Increased * 1  1/55 (1.82%)  0/50 (0.00%) 
Ggt Increased * 1  1/55 (1.82%)  0/50 (0.00%) 
Creatinine Increased * 1  7/55 (12.73%)  5/50 (10.00%) 
Neutrophil Count Decreased * 1  25/55 (45.45%)  28/50 (56.00%) 
Blood Bilirubin Increased * 1  7/55 (12.73%)  0/50 (0.00%) 
White Blood Cell Decreased * 1  31/55 (56.36%)  32/50 (64.00%) 
Aspartate Aminotransferase Increased * 1  34/55 (61.82%)  6/50 (12.00%) 
Alkaline Phosphatase Increased * 1  21/55 (38.18%)  8/50 (16.00%) 
Alanine Aminotransferase Increased * 1  30/55 (54.55%)  4/50 (8.00%) 
Activated Partial Thromboplastin Time Prolonged * 1  2/55 (3.64%)  0/50 (0.00%) 
Metabolism and nutrition disorders     
Hypophosphatemia * 1  16/55 (29.09%)  3/50 (6.00%) 
Hyponatremia * 1  9/55 (16.36%)  5/50 (10.00%) 
Hypomagnesemia * 1  27/55 (49.09%)  19/50 (38.00%) 
Hypokalemia * 1  15/55 (27.27%)  5/50 (10.00%) 
Hypoglycemia * 1  1/55 (1.82%)  2/50 (4.00%) 
Hypocalcemia * 1  15/55 (27.27%)  6/50 (12.00%) 
Hypoalbuminemia * 1  15/55 (27.27%)  9/50 (18.00%) 
Hyperuricemia * 1  1/55 (1.82%)  0/50 (0.00%) 
Hypernatremia * 1  1/55 (1.82%)  2/50 (4.00%) 
Hypermagnesemia * 1  2/55 (3.64%)  0/50 (0.00%) 
Hyperkalemia * 1  2/55 (3.64%)  2/50 (4.00%) 
Hyperglycemia * 1  5/55 (9.09%)  12/50 (24.00%) 
Hypercalcemia * 1  2/55 (3.64%)  1/50 (2.00%) 
Dehydration * 1  4/55 (7.27%)  2/50 (4.00%) 
Anorexia * 1  25/55 (45.45%)  7/50 (14.00%) 
Musculoskeletal and connective tissue disorders     
Pain In Extremity * 1  4/55 (7.27%)  7/50 (14.00%) 
Neck Pain * 1  1/55 (1.82%)  1/50 (2.00%) 
Myalgia * 1  10/55 (18.18%)  7/50 (14.00%) 
Generalized Muscle Weakness * 1  6/55 (10.91%)  0/50 (0.00%) 
Flank Pain * 1  1/55 (1.82%)  0/50 (0.00%) 
Chest Wall Pain * 1  0/55 (0.00%)  1/50 (2.00%) 
Buttock Pain * 1  0/55 (0.00%)  1/50 (2.00%) 
Bone Pain * 1  1/55 (1.82%)  2/50 (4.00%) 
Back Pain * 1  9/55 (16.36%)  6/50 (12.00%) 
Arthritis * 1  1/55 (1.82%)  0/50 (0.00%) 
Arthralgia * 1  5/55 (9.09%)  5/50 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms Benign, Malignant And Unspecified (Incl * 1  1/55 (1.82%)  0/50 (0.00%) 
Nervous system disorders     
Tremor * 1  0/55 (0.00%)  2/50 (4.00%) 
Peripheral Sensory Neuropathy * 1  13/55 (23.64%)  28/50 (56.00%) 
Peripheral Motor Neuropathy * 1  2/55 (3.64%)  3/50 (6.00%) 
Paresthesia * 1  1/55 (1.82%)  1/50 (2.00%) 
Memory Impairment * 1  1/55 (1.82%)  0/50 (0.00%) 
Movements Involuntary * 1  0/55 (0.00%)  1/50 (2.00%) 
Headache * 1  14/55 (25.45%)  8/50 (16.00%) 
Dysgeusia * 1  15/55 (27.27%)  2/50 (4.00%) 
Dizziness * 1  11/55 (20.00%)  2/50 (4.00%) 
Concentration Impairment * 1  0/55 (0.00%)  1/50 (2.00%) 
Cognitive Disturbance * 1  1/55 (1.82%)  0/50 (0.00%) 
Ataxia * 1  2/55 (3.64%)  2/50 (4.00%) 
Akathisia * 1  0/55 (0.00%)  1/50 (2.00%) 
Psychiatric disorders     
Personality Change * 1  0/55 (0.00%)  1/50 (2.00%) 
Restlessness * 1  0/55 (0.00%)  2/50 (4.00%) 
Libido Decreased * 1  1/55 (1.82%)  0/50 (0.00%) 
Insomnia * 1  8/55 (14.55%)  11/50 (22.00%) 
Euphoria * 1  2/55 (3.64%)  0/50 (0.00%) 
Depression * 1  9/55 (16.36%)  6/50 (12.00%) 
Delirium * 1  1/55 (1.82%)  0/50 (0.00%) 
Confusion * 1  2/55 (3.64%)  0/50 (0.00%) 
Anxiety * 1  7/55 (12.73%)  5/50 (10.00%) 
Agitation * 1  2/55 (3.64%)  0/50 (0.00%) 
Renal and urinary disorders     
Urine Discoloration * 1  1/55 (1.82%)  0/50 (0.00%) 
Urinary Urgency * 1  1/55 (1.82%)  1/50 (2.00%) 
Urinary Tract Obstruction * 1  1/55 (1.82%)  0/50 (0.00%) 
Urinary Retention * 1  1/55 (1.82%)  0/50 (0.00%) 
Urinary Incontinence * 1  1/55 (1.82%)  3/50 (6.00%) 
Urinary Tract Pain * 1  1/55 (1.82%)  0/50 (0.00%) 
Urinary Frequency * 1  4/55 (7.27%)  0/50 (0.00%) 
Renal Colic * 1  1/55 (1.82%)  0/50 (0.00%) 
Proteinuria * 1  2/55 (3.64%)  1/50 (2.00%) 
Hemoglobinuria * 1  0/55 (0.00%)  1/50 (2.00%) 
Hematuria * 1  3/55 (5.45%)  0/50 (0.00%) 
Cystitis Noninfective * 1  0/55 (0.00%)  1/50 (2.00%) 
Reproductive system and breast disorders     
Vaginal Hemorrhage * 1  2/55 (3.64%)  2/50 (4.00%) 
Pelvic Pain * 1  3/55 (5.45%)  2/50 (4.00%) 
Vaginal Discharge * 1  1/55 (1.82%)  2/50 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, Thoracic And Mediastinal Disorders - * 1  2/55 (3.64%)  0/50 (0.00%) 
Voice Alteration * 1  7/55 (12.73%)  0/50 (0.00%) 
Sore Throat * 1  3/55 (5.45%)  0/50 (0.00%) 
Sinus Disorder * 1  1/55 (1.82%)  1/50 (2.00%) 
Postnasal Drip * 1  1/55 (1.82%)  2/50 (4.00%) 
Pleural Effusion * 1  1/55 (1.82%)  1/50 (2.00%) 
Pharyngolaryngeal Pain * 1  1/55 (1.82%)  0/50 (0.00%) 
Nasal Congestion * 1  2/55 (3.64%)  2/50 (4.00%) 
Pleuritic Pain * 1  1/55 (1.82%)  1/50 (2.00%) 
Productive Cough * 1  0/55 (0.00%)  2/50 (4.00%) 
Hypoxia * 1  0/55 (0.00%)  1/50 (2.00%) 
Hoarseness * 1  4/55 (7.27%)  1/50 (2.00%) 
Epistaxis * 1  3/55 (5.45%)  4/50 (8.00%) 
Dyspnea * 1  11/55 (20.00%)  13/50 (26.00%) 
Cough * 1  13/55 (23.64%)  7/50 (14.00%) 
Bronchial Obstruction * 1  0/55 (0.00%)  1/50 (2.00%) 
Allergic Rhinitis * 1  0/55 (0.00%)  1/50 (2.00%) 
Skin and subcutaneous tissue disorders     
Skin And Subcutaneous Tissue Disorders - Other * 1  1/55 (1.82%)  0/50 (0.00%) 
Skin Ulceration * 1  0/55 (0.00%)  1/50 (2.00%) 
Skin Hyperpigmentation * 1  1/55 (1.82%)  0/50 (0.00%) 
Rash Acneiform * 1  2/55 (3.64%)  3/50 (6.00%) 
Pruritus * 1  2/55 (3.64%)  3/50 (6.00%) 
Palmar-Plantar Erythrodysesthesia Syndrome * 1  18/55 (32.73%)  1/50 (2.00%) 
Pain Of Skin * 1  1/55 (1.82%)  0/50 (0.00%) 
Rash Maculo-Papular * 1  11/55 (20.00%)  7/50 (14.00%) 
Skin Hypopigmentation * 1  4/55 (7.27%)  0/50 (0.00%) 
Nail Loss * 1  0/55 (0.00%)  3/50 (6.00%) 
Nail Discoloration * 1  0/55 (0.00%)  5/50 (10.00%) 
Erythema Multiforme * 1  1/55 (1.82%)  0/50 (0.00%) 
Dry Skin * 1  5/55 (9.09%)  3/50 (6.00%) 
Alopecia * 1  11/55 (20.00%)  31/50 (62.00%) 
Vascular disorders     
Thromboembolic Event * 1  6/55 (10.91%)  3/50 (6.00%) 
Lymphedema * 1  0/55 (0.00%)  2/50 (4.00%) 
Hypotension * 1  1/55 (1.82%)  1/50 (2.00%) 
Hypertension * 1  24/55 (43.64%)  5/50 (10.00%) 
Hot Flashes * 1  3/55 (5.45%)  5/50 (10.00%) 
Hematoma * 1  2/55 (3.64%)  0/50 (0.00%) 
Flushing * 1  0/55 (0.00%)  1/50 (2.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[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: Linda Gedeon on behalf of Michael Sill, PhD.
Organization: NRG Oncology
Phone: 716-845-1169
EMail: lgedeon@gogstats.org
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: NCT01716715    
Other Study ID Numbers: NCI-2012-02058
NCI-2012-02058 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0186K
S13-00312
GOG-0186K ( Other Identifier: NRG Oncology )
GOG-0186K ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: October 23, 2012
First Posted: October 30, 2012
Results First Submitted: June 26, 2019
Results First Posted: March 10, 2020
Last Update Posted: March 10, 2020