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Bevacizumab With or Without Fosbretabulin Tromethamine in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

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ClinicalTrials.gov Identifier: NCT01305213
Recruitment Status : Completed
First Posted : February 28, 2011
Results First Posted : July 12, 2017
Last Update Posted : October 23, 2017
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 Biological: Bevacizumab
Drug: Fosbretabulin Tromethamine
Other: Laboratory Biomarker Analysis
Enrollment 107

Recruitment Details The study was activated on 3/21/2011 and closed on 4/22/2013
Pre-assignment Details  
Arm/Group Title Arm I Bevacizumab Arm II Bevacizumab + Fosbretabulin
Hide Arm/Group Description Bevacizumab 15mg/kg IV Day 1 every 3 weeks Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
Period Title: Overall Study
Started 53 54
Completed 53 54
Not Completed 0 0
Arm/Group Title Arm I Bevacizumab Arm II Bevacizumab + Fosbretabulin Total
Hide Arm/Group Description Bevacizumab 15mg/kg IV Day 1 every 3 weeks Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks Total of all reporting groups
Overall Number of Baseline Participants 53 54 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 54 participants 107 participants
64.3  (12) 64.9  (10.3) 64.6  (11.15)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 54 participants 107 participants
30 - 39 years
2
   3.8%
0
   0.0%
2
   1.9%
40 - 49 years
3
   5.7%
5
   9.3%
8
   7.5%
50 - 59 years
12
  22.6%
12
  22.2%
24
  22.4%
60 - 69 years
19
  35.8%
15
  27.8%
34
  31.8%
70 - 79 years
13
  24.5%
19
  35.2%
32
  29.9%
> = 80 years
4
   7.5%
3
   5.6%
7
   6.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 54 participants 107 participants
Female
53
 100.0%
54
 100.0%
107
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored.
Time Frame For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All intent to treat patients
Arm/Group Title Arm I Bevacizumab Arm II Bevacizumab + Fosbretabulin
Hide Arm/Group Description:
Bevacizumab 15mg/kg IV Day 1 every 3 weeks
Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
Overall Number of Participants Analyzed 53 54
Median (95% Confidence Interval)
Unit of Measure: months
4.83
(4.14 to 6.24)
7.23
(4.30 to 10.51)
2.Secondary Outcome
Title Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0
Hide Description Toxicities will be characterized by their frequency and severity. Differences in the level of toxicities by treatment regimen will be assessed by classifying them as severe or not severe and examining the relative proportion of severe toxicities.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible and treated patients
Arm/Group Title Arm I Bevacizumab Arm II Bevacizumab + Fosbretabulin
Hide Arm/Group Description:
Bevacizumab 15mg/kg IV Day 1 every 3 weeks
Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
Overall Number of Participants Analyzed 53 54
Measure Type: Count of Participants
Unit of Measure: Participants
Thrombocytopenia
0
   0.0%
1
   1.9%
Neutropenia
3
   5.7%
1
   1.9%
Other Investigations
1
   1.9%
4
   7.4%
Other Blood/Lymphatics
0
   0.0%
1
   1.9%
Cardiac
1
   1.9%
1
   1.9%
Nausea
2
   3.8%
3
   5.6%
Vomiting
0
   0.0%
2
   3.7%
Other Gastrointestinal
5
   9.4%
8
  14.8%
General and Administration Site
2
   3.8%
3
   5.6%
Infections/Infestations
3
   5.7%
3
   5.6%
Metabolism/Nutrition
8
  15.1%
11
  20.4%
Musculoskeletal/Connective tissue
2
   3.8%
2
   3.7%
Neoplasms Benign/Malignant
1
   1.9%
0
   0.0%
Peripheral sensory Neuropathy
0
   0.0%
1
   1.9%
Nervous system
1
   1.9%
2
   3.7%
Renal/Urinary
0
   0.0%
2
   3.7%
Respiratory/Thoracic/Mediastinal
2
   3.8%
1
   1.9%
Vascular Disorders
10
  18.9%
19
  35.2%
3.Secondary Outcome
Title Measurable Disease by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria and Progression Free Survival (PFS)
Hide Description Differences between measurable versus non-measurable disease status on PFS and OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non Measurable Disease Patients Measurable Disease Patients
Hide Arm/Group Description:
Patients with non measurable disease
Patients with measurable disease
Overall Number of Participants Analyzed 26 81
Median (95% Confidence Interval)
Unit of Measure: months
3.99
(2.73 to 5.19)
6.80
(5.29 to 8.67)
4.Secondary Outcome
Title Tumor Response
Hide Description Complete and Partial Tumor Response by RECIST 1.0
Time Frame for those patients whose disease can be evaluated by physical examination, response wa assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with measurable disease
Arm/Group Title Arm I Bevacizumab Arm II Bevacizumab + Fosbretabulin
Hide Arm/Group Description:
Bevacizumab 15mg/kg IV Day 1 every 3 weeks
Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
Overall Number of Participants Analyzed 39 42
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
28.2
(16.7 to 42.3)
35.7
(23.5 to 49.5)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Differences between measurable versus non-measurable disease status on PFS and OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non Measurble Disease Measurable Disease Patients
Hide Arm/Group Description:
Patients with non measurable disease
Patients with measurable disease
Overall Number of Participants Analyzed 26 81
Median (90% Confidence Interval)
Unit of Measure: months
22.0 [1] 
(13.3 to NA)
21.2 [1] 
(19.8 to NA)
[1]
The proportion of patients who died at the time of the analysis was insufficient to estimate the upper bound of the confidence interval.
6.Secondary Outcome
Title Response by CA-125
Hide Description The effects of treatment on the proportion responding by CA125 will be examined.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Bevacizumab Arm II Bevacizumab + Fosbretabulin
Hide Arm/Group Description:
Bevacizumab 15mg/kg IV Day 1 every 3 weeks
Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
Overall Number of Participants Analyzed 38 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
23.7
(11.4 to 40.2)
33.3
(16.5 to 54.0)
Time Frame All adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I Bevacizumab Arm II Bevacizumab + Fosbretabulin
Hide Arm/Group Description Bevacizumab 15mg/kg IV Day 1 every 3 weeks Bevacizumab 15mg/kg IV Day 1 every 3 weeks plus fosbretabulin tromethamine 60mg/m2 IV Day 1 every 3 weeks
All-Cause Mortality
Arm I Bevacizumab Arm II Bevacizumab + Fosbretabulin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Bevacizumab Arm II Bevacizumab + Fosbretabulin
Affected / at Risk (%) Affected / at Risk (%)
Total   9/53 (16.98%)   16/54 (29.63%) 
Cardiac disorders     
Atrial Fibrillation * 1  0/53 (0.00%)  2/54 (3.70%) 
Chest Pain - Cardiac * 1  1/53 (1.89%)  0/54 (0.00%) 
Gastrointestinal disorders     
Constipation * 1  0/53 (0.00%)  1/54 (1.85%) 
Vomiting * 1  0/53 (0.00%)  1/54 (1.85%) 
Abdominal Pain * 1  0/53 (0.00%)  1/54 (1.85%) 
Obstruction Gastric * 1  0/53 (0.00%)  1/54 (1.85%) 
Gastrointestinal Disorders - Other * 1  0/53 (0.00%)  1/54 (1.85%) 
Ileus * 1  1/53 (1.89%)  0/54 (0.00%) 
Gastrointestinal Fistula * 1  1/53 (1.89%)  0/54 (0.00%) 
Ascites * 1  1/53 (1.89%)  0/54 (0.00%) 
Infections and infestations     
Pleural Infection * 1  1/53 (1.89%)  0/54 (0.00%) 
Pelvic Infection * 1  0/53 (0.00%)  1/54 (1.85%) 
Device Related Infection * 1  0/53 (0.00%)  1/54 (1.85%) 
Investigations     
Inr Increased * 1  1/53 (1.89%)  0/54 (0.00%) 
Electrocardiogram Qt Corrected Interval Prolonged * 1  0/53 (0.00%)  1/54 (1.85%) 
Metabolism and nutrition disorders     
Hypomagnesemia * 1  1/53 (1.89%)  0/54 (0.00%) 
Hyperkalemia * 1  1/53 (1.89%)  0/54 (0.00%) 
Dehydration * 1  0/53 (0.00%)  2/54 (3.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms Benign, Malignant And Unspecified (Incl * 1  1/53 (1.89%)  0/54 (0.00%) 
Renal and urinary disorders     
Proteinuria * 1  0/53 (0.00%)  1/54 (1.85%) 
Vascular disorders     
Thromboembolic Event * 1  0/53 (0.00%)  1/54 (1.85%) 
Hypertension * 1  1/53 (1.89%)  3/54 (5.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I Bevacizumab Arm II Bevacizumab + Fosbretabulin
Affected / at Risk (%) Affected / at Risk (%)
Total   53/53 (100.00%)   52/54 (96.30%) 
Blood and lymphatic system disorders     
Leukocytosis * 1  0/53 (0.00%)  1/54 (1.85%) 
Anemia * 1  23/53 (43.40%)  19/54 (35.19%) 
Cardiac disorders     
Atrial Fibrillation * 1  0/53 (0.00%)  2/54 (3.70%) 
Sinus Bradycardia * 1  1/53 (1.89%)  3/54 (5.56%) 
Palpitations * 1  5/53 (9.43%)  4/54 (7.41%) 
Sinus Tachycardia * 1  0/53 (0.00%)  2/54 (3.70%) 
Chest Pain - Cardiac * 1  1/53 (1.89%)  1/54 (1.85%) 
Ear and labyrinth disorders     
Tinnitus * 1  5/53 (9.43%)  3/54 (5.56%) 
Hearing Impaired * 1  5/53 (9.43%)  3/54 (5.56%) 
Ear Pain * 1  3/53 (5.66%)  2/54 (3.70%) 
Eye disorders     
Eye Disorders - Other * 1  1/53 (1.89%)  0/54 (0.00%) 
Watering Eyes * 1  2/53 (3.77%)  0/54 (0.00%) 
Flashing Lights * 1  2/53 (3.77%)  1/54 (1.85%) 
Eye Pain * 1  1/53 (1.89%)  0/54 (0.00%) 
Photophobia * 1  0/53 (0.00%)  1/54 (1.85%) 
Blurred Vision * 1  4/53 (7.55%)  7/54 (12.96%) 
Dry Eye * 1  0/53 (0.00%)  1/54 (1.85%) 
Floaters * 1  3/53 (5.66%)  2/54 (3.70%) 
Gastrointestinal disorders     
Dysphagia * 1  2/53 (3.77%)  2/54 (3.70%) 
Dyspepsia * 1  0/53 (0.00%)  5/54 (9.26%) 
Dry Mouth * 1  0/53 (0.00%)  5/54 (9.26%) 
Colonic Obstruction * 1  0/53 (0.00%)  1/54 (1.85%) 
Constipation * 1  16/53 (30.19%)  25/54 (46.30%) 
Diarrhea * 1  16/53 (30.19%)  21/54 (38.89%) 
Vomiting * 1  8/53 (15.09%)  17/54 (31.48%) 
Bloating * 1  6/53 (11.32%)  7/54 (12.96%) 
Stomach Pain * 1  1/53 (1.89%)  2/54 (3.70%) 
Small Intestinal Obstruction * 1  0/53 (0.00%)  3/54 (5.56%) 
Abdominal Pain * 1  19/53 (35.85%)  22/54 (40.74%) 
Rectal Hemorrhage * 1  1/53 (1.89%)  4/54 (7.41%) 
Oral Dysesthesia * 1  1/53 (1.89%)  3/54 (5.56%) 
Mucositis Oral * 1  7/53 (13.21%)  10/54 (18.52%) 
Lower Gastrointestinal Hemorrhage * 1  0/53 (0.00%)  1/54 (1.85%) 
Oral Pain * 1  0/53 (0.00%)  4/54 (7.41%) 
Abdominal Distension * 1  3/53 (5.66%)  3/54 (5.56%) 
Nausea * 1  22/53 (41.51%)  22/54 (40.74%) 
Gastroesophageal Reflux Disease * 1  3/53 (5.66%)  2/54 (3.70%) 
Rectal Pain * 1  1/53 (1.89%)  0/54 (0.00%) 
Esophageal Ulcer * 1  0/53 (0.00%)  1/54 (1.85%) 
Fecal Incontinence * 1  1/53 (1.89%)  1/54 (1.85%) 
Hemorrhoidal Hemorrhage * 1  0/53 (0.00%)  1/54 (1.85%) 
Hemorrhoids * 1  0/53 (0.00%)  1/54 (1.85%) 
Tooth Development Disorder * 1  0/53 (0.00%)  1/54 (1.85%) 
Ascites * 1  4/53 (7.55%)  2/54 (3.70%) 
Toothache * 1  0/53 (0.00%)  2/54 (3.70%) 
Dental Caries * 1  0/53 (0.00%)  1/54 (1.85%) 
Flatulence * 1  1/53 (1.89%)  2/54 (3.70%) 
General disorders     
General Disorders And Administration Site Conditio * 1  1/53 (1.89%)  0/54 (0.00%) 
Pain * 1  7/53 (13.21%)  14/54 (25.93%) 
Malaise * 1  2/53 (3.77%)  1/54 (1.85%) 
Localized Edema * 1  1/53 (1.89%)  0/54 (0.00%) 
Flu Like Symptoms * 1  0/53 (0.00%)  3/54 (5.56%) 
Non-Cardiac Chest Pain * 1  0/53 (0.00%)  3/54 (5.56%) 
Edema Limbs * 1  9/53 (16.98%)  0/54 (0.00%) 
Fatigue * 1  35/53 (66.04%)  42/54 (77.78%) 
Fever * 1  4/53 (7.55%)  8/54 (14.81%) 
Gait Disturbance * 1  0/53 (0.00%)  2/54 (3.70%) 
Chills * 1  0/53 (0.00%)  4/54 (7.41%) 
Infusion Related Reaction * 1  0/53 (0.00%)  2/54 (3.70%) 
Immune system disorders     
Allergic Reaction * 1  0/53 (0.00%)  1/54 (1.85%) 
Infections and infestations     
Infections And Infestations - Other * 1  1/53 (1.89%)  2/54 (3.70%) 
Wound Infection * 1  2/53 (3.77%)  1/54 (1.85%) 
Upper Respiratory Infection * 1  2/53 (3.77%)  2/54 (3.70%) 
Tooth Infection * 1  1/53 (1.89%)  1/54 (1.85%) 
Skin Infection * 1  2/53 (3.77%)  1/54 (1.85%) 
Sinusitis * 1  4/53 (7.55%)  2/54 (3.70%) 
Rash Pustular * 1  0/53 (0.00%)  1/54 (1.85%) 
Papulopustular Rash * 1  0/53 (0.00%)  1/54 (1.85%) 
Mucosal Infection * 1  0/53 (0.00%)  1/54 (1.85%) 
Device Related Infection * 1  1/53 (1.89%)  0/54 (0.00%) 
Gum Infection * 1  0/53 (0.00%)  1/54 (1.85%) 
Vaginal Infection * 1  1/53 (1.89%)  1/54 (1.85%) 
Urinary Tract Infection * 1  10/53 (18.87%)  7/54 (12.96%) 
Bronchial Infection * 1  2/53 (3.77%)  2/54 (3.70%) 
Injury, poisoning and procedural complications     
Injury, Poisoning And Procedural Complications - O * 1  1/53 (1.89%)  2/54 (3.70%) 
Fracture * 1  1/53 (1.89%)  1/54 (1.85%) 
Fall * 1  1/53 (1.89%)  0/54 (0.00%) 
Wound Complication * 1  1/53 (1.89%)  1/54 (1.85%) 
Bruising * 1  4/53 (7.55%)  1/54 (1.85%) 
Investigations     
Investigations - Other * 1  1/53 (1.89%)  1/54 (1.85%) 
Weight Loss * 1  8/53 (15.09%)  6/54 (11.11%) 
Weight Gain * 1  1/53 (1.89%)  0/54 (0.00%) 
Platelet Count Decreased * 1  6/53 (11.32%)  10/54 (18.52%) 
Lymphocyte Count Decreased * 1  4/53 (7.55%)  2/54 (3.70%) 
Inr Increased * 1  0/53 (0.00%)  2/54 (3.70%) 
Electrocardiogram Qt Corrected Interval Prolonged * 1  0/53 (0.00%)  4/54 (7.41%) 
Creatinine Increased * 1  10/53 (18.87%)  3/54 (5.56%) 
Cholesterol High * 1  1/53 (1.89%)  0/54 (0.00%) 
Cardiac Troponin T Increased * 1  1/53 (1.89%)  0/54 (0.00%) 
Neutrophil Count Decreased * 1  7/53 (13.21%)  8/54 (14.81%) 
Cardiac Troponin I Increased * 1  0/53 (0.00%)  1/54 (1.85%) 
Blood Bilirubin Increased * 1  2/53 (3.77%)  4/54 (7.41%) 
White Blood Cell Decreased * 1  11/53 (20.75%)  8/54 (14.81%) 
Aspartate Aminotransferase Increased * 1  8/53 (15.09%)  11/54 (20.37%) 
Alkaline Phosphatase Increased * 1  4/53 (7.55%)  8/54 (14.81%) 
Alanine Aminotransferase Increased * 1  3/53 (5.66%)  6/54 (11.11%) 
Activated Partial Thromboplastin Time Prolonged * 1  0/53 (0.00%)  1/54 (1.85%) 
Metabolism and nutrition disorders     
Hypophosphatemia * 1  2/53 (3.77%)  2/54 (3.70%) 
Hyponatremia * 1  12/53 (22.64%)  9/54 (16.67%) 
Hypomagnesemia * 1  15/53 (28.30%)  13/54 (24.07%) 
Hypokalemia * 1  8/53 (15.09%)  6/54 (11.11%) 
Hypoglycemia * 1  4/53 (7.55%)  4/54 (7.41%) 
Hypocalcemia * 1  8/53 (15.09%)  10/54 (18.52%) 
Hypoalbuminemia * 1  10/53 (18.87%)  9/54 (16.67%) 
Hypertriglyceridemia * 1  1/53 (1.89%)  0/54 (0.00%) 
Hypernatremia * 1  2/53 (3.77%)  1/54 (1.85%) 
Hypermagnesemia * 1  2/53 (3.77%)  6/54 (11.11%) 
Hyperkalemia * 1  7/53 (13.21%)  4/54 (7.41%) 
Hyperglycemia * 1  17/53 (32.08%)  16/54 (29.63%) 
Hypercalcemia * 1  1/53 (1.89%)  2/54 (3.70%) 
Dehydration * 1  1/53 (1.89%)  3/54 (5.56%) 
Anorexia * 1  9/53 (16.98%)  13/54 (24.07%) 
Musculoskeletal and connective tissue disorders     
Pain In Extremity * 1  9/53 (16.98%)  9/54 (16.67%) 
Neck Pain * 1  3/53 (5.66%)  2/54 (3.70%) 
Myalgia * 1  7/53 (13.21%)  14/54 (25.93%) 
Muscle Weakness Upper Limb * 1  0/53 (0.00%)  1/54 (1.85%) 
Muscle Weakness Lower Limb * 1  1/53 (1.89%)  2/54 (3.70%) 
Joint Range Of Motion Decreased * 1  1/53 (1.89%)  0/54 (0.00%) 
Generalized Muscle Weakness * 1  3/53 (5.66%)  5/54 (9.26%) 
Flank Pain * 1  1/53 (1.89%)  0/54 (0.00%) 
Buttock Pain * 1  0/53 (0.00%)  1/54 (1.85%) 
Bone Pain * 1  0/53 (0.00%)  1/54 (1.85%) 
Back Pain * 1  12/53 (22.64%)  5/54 (9.26%) 
Arthritis * 1  4/53 (7.55%)  4/54 (7.41%) 
Arthralgia * 1  23/53 (43.40%)  17/54 (31.48%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor Pain * 1  0/53 (0.00%)  1/54 (1.85%) 
Nervous system disorders     
Nervous System Disorders - Other * 1  1/53 (1.89%)  0/54 (0.00%) 
Tremor * 1  1/53 (1.89%)  1/54 (1.85%) 
Peripheral Sensory Neuropathy * 1  26/53 (49.06%)  24/54 (44.44%) 
Peripheral Motor Neuropathy * 1  2/53 (3.77%)  2/54 (3.70%) 
Paresthesia * 1  0/53 (0.00%)  1/54 (1.85%) 
Neuralgia * 1  1/53 (1.89%)  1/54 (1.85%) 
Memory Impairment * 1  2/53 (3.77%)  2/54 (3.70%) 
Movements Involuntary * 1  1/53 (1.89%)  0/54 (0.00%) 
Headache * 1  18/53 (33.96%)  21/54 (38.89%) 
Extrapyramidal Disorder * 1  0/53 (0.00%)  1/54 (1.85%) 
Dysphasia * 1  1/53 (1.89%)  0/54 (0.00%) 
Dysgeusia * 1  3/53 (5.66%)  1/54 (1.85%) 
Syncope * 1  0/53 (0.00%)  1/54 (1.85%) 
Dizziness * 1  4/53 (7.55%)  6/54 (11.11%) 
Cognitive Disturbance * 1  0/53 (0.00%)  2/54 (3.70%) 
Ataxia * 1  0/53 (0.00%)  1/54 (1.85%) 
Psychiatric disorders     
Insomnia * 1  5/53 (9.43%)  11/54 (20.37%) 
Depression * 1  8/53 (15.09%)  10/54 (18.52%) 
Confusion * 1  0/53 (0.00%)  1/54 (1.85%) 
Anxiety * 1  9/53 (16.98%)  7/54 (12.96%) 
Renal and urinary disorders     
Urinary Urgency * 1  0/53 (0.00%)  2/54 (3.70%) 
Urinary Retention * 1  1/53 (1.89%)  2/54 (3.70%) 
Urinary Incontinence * 1  4/53 (7.55%)  4/54 (7.41%) 
Urinary Tract Pain * 1  5/53 (9.43%)  4/54 (7.41%) 
Urinary Frequency * 1  4/53 (7.55%)  3/54 (5.56%) 
Proteinuria * 1  9/53 (16.98%)  6/54 (11.11%) 
Hematuria * 1  2/53 (3.77%)  0/54 (0.00%) 
Chronic Kidney Disease * 1  1/53 (1.89%)  1/54 (1.85%) 
Acute Kidney Injury * 1  1/53 (1.89%)  0/54 (0.00%) 
Reproductive system and breast disorders     
Vaginal Pain * 1  0/53 (0.00%)  1/54 (1.85%) 
Vaginal Hemorrhage * 1  1/53 (1.89%)  4/54 (7.41%) 
Pelvic Pain * 1  3/53 (5.66%)  2/54 (3.70%) 
Vaginal Discharge * 1  0/53 (0.00%)  1/54 (1.85%) 
Breast Pain * 1  0/53 (0.00%)  1/54 (1.85%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, Thoracic And Mediastinal Disorders - * 1  0/53 (0.00%)  1/54 (1.85%) 
Voice Alteration * 1  1/53 (1.89%)  0/54 (0.00%) 
Sore Throat * 1  3/53 (5.66%)  0/54 (0.00%) 
Sinus Disorder * 1  1/53 (1.89%)  0/54 (0.00%) 
Postnasal Drip * 1  5/53 (9.43%)  2/54 (3.70%) 
Pleural Effusion * 1  2/53 (3.77%)  1/54 (1.85%) 
Nasal Congestion * 1  4/53 (7.55%)  3/54 (5.56%) 
Pleuritic Pain * 1  1/53 (1.89%)  0/54 (0.00%) 
Productive Cough * 1  1/53 (1.89%)  0/54 (0.00%) 
Hypoxia * 1  1/53 (1.89%)  0/54 (0.00%) 
Hoarseness * 1  3/53 (5.66%)  7/54 (12.96%) 
Epistaxis * 1  11/53 (20.75%)  4/54 (7.41%) 
Dyspnea * 1  17/53 (32.08%)  15/54 (27.78%) 
Cough * 1  17/53 (32.08%)  10/54 (18.52%) 
Wheezing * 1  0/53 (0.00%)  1/54 (1.85%) 
Bronchopulmonary Hemorrhage * 1  1/53 (1.89%)  0/54 (0.00%) 
Atelectasis * 1  1/53 (1.89%)  0/54 (0.00%) 
Allergic Rhinitis * 1  8/53 (15.09%)  2/54 (3.70%) 
Skin and subcutaneous tissue disorders     
Urticaria * 1  0/53 (0.00%)  2/54 (3.70%) 
Rash Acneiform * 1  1/53 (1.89%)  2/54 (3.70%) 
Pruritus * 1  3/53 (5.66%)  6/54 (11.11%) 
Palmar-Plantar Erythrodysesthesia Syndrome * 1  0/53 (0.00%)  1/54 (1.85%) 
Pain Of Skin * 1  0/53 (0.00%)  1/54 (1.85%) 
Rash Maculo-Papular * 1  3/53 (5.66%)  7/54 (12.96%) 
Nail Loss * 1  0/53 (0.00%)  2/54 (3.70%) 
Nail Discoloration * 1  1/53 (1.89%)  2/54 (3.70%) 
Hyperhidrosis * 1  1/53 (1.89%)  1/54 (1.85%) 
Erythema Multiforme * 1  0/53 (0.00%)  1/54 (1.85%) 
Dry Skin * 1  2/53 (3.77%)  4/54 (7.41%) 
Alopecia * 1  5/53 (9.43%)  9/54 (16.67%) 
Vascular disorders     
Thromboembolic Event * 1  0/53 (0.00%)  1/54 (1.85%) 
Lymphedema * 1  1/53 (1.89%)  0/54 (0.00%) 
Hypotension * 1  2/53 (3.77%)  3/54 (5.56%) 
Hypertension * 1  28/53 (52.83%)  32/54 (59.26%) 
Hot Flashes * 1  1/53 (1.89%)  8/54 (14.81%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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
Name/Title: Linda Gedeon for Michael Sill, PhD
Organization: NRG Oncology
Phone: 716-845-1169
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01305213     History of Changes
Other Study ID Numbers: NCI-2011-02666
NCI-2011-02666 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000696220
GOG-0186I ( Other Identifier: NRG Oncology )
GOG-0186I ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: February 25, 2011
First Posted: February 28, 2011
Results First Submitted: June 14, 2017
Results First Posted: July 12, 2017
Last Update Posted: October 23, 2017