Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 54 of 526 for:    "Primary Peritoneal Carcinoma"

Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or 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: NCT01468909
Recruitment Status : Completed
First Posted : November 10, 2011
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Interventions Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Drug: Pazopanib Hydrochloride
Other: Placebo
Enrollment 106
Recruitment Details 106 patients were enrolled between December 2011 and April 2013.
Pre-assignment Details  
Arm/Group Title Paclitaxel + Placebo Paclitaxel + Pazopanib
Hide Arm/Group Description Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
Period Title: Overall Study
Started 52 54
Completed 50 52
Not Completed 2 2
Reason Not Completed
Never Treated             2             2
Arm/Group Title Paclitaxel + Placebo Paclitaxel + Pazopanib Total
Hide Arm/Group Description Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily Total of all reporting groups
Overall Number of Baseline Participants 52 54 106
Hide Baseline Analysis Population Description
All registered patients
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 52 participants 54 participants 106 participants
30-39 years
2
   3.8%
1
   1.9%
3
   2.8%
40-49 years
7
  13.5%
5
   9.3%
12
  11.3%
50-59 years
14
  26.9%
17
  31.5%
31
  29.2%
60-69 years
18
  34.6%
18
  33.3%
36
  34.0%
70-79 years
10
  19.2%
10
  18.5%
20
  18.9%
80 + years
1
   1.9%
3
   5.6%
4
   3.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 54 participants 106 participants
Female
52
 100.0%
54
 100.0%
106
 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 52 participants 54 participants 106 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
  11.5%
3
   5.6%
9
   8.5%
Native Hawaiian or Other Pacific Islander
1
   1.9%
0
   0.0%
1
   0.9%
Black or African American
3
   5.8%
4
   7.4%
7
   6.6%
White
42
  80.8%
46
  85.2%
88
  83.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.9%
1
   0.9%
1.Primary Outcome
Title Progression Free Survival
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. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Paclitaxel + Placebo Paclitaxel + Pazopanib
Hide Arm/Group Description:
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
Overall Number of Participants Analyzed 52 54
Median (95% Confidence Interval)
Unit of Measure: months
6.2
(5.5 to 8.5)
7.5
(5.3 to 9.1)
2.Secondary Outcome
Title Adverse Events as Assessed by CTCAE v.4
Hide Description All grade 3 or greater Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
Time Frame From baseline to 30 days after last dose of drug.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated and eligible patients
Arm/Group Title Paclitaxel + Placebo Paclitaxel + Pazopanib
Hide Arm/Group Description:
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
Overall Number of Participants Analyzed 50 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
18
(11 to 26)
45
(38 to 49)
3.Secondary Outcome
Title Proportion of Participants With Tumor Response by RECIST
Hide Description Patients with Complete and Partial Tumor Response by RECIST 1.1. Responses (CR and PR) require confirmation at greater than or equal to 4 weeks from initial documentation. 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 Every other cycle for 6 months, then every 3 months until disease progression,Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients.
Arm/Group Title Paclitaxel + Placebo Paclitaxel + Pazopanib
Hide Arm/Group Description:
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
Overall Number of Participants Analyzed 52 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.192
(0.096 to 0.325)
0.259
(0.150 to 0.397)
4.Secondary Outcome
Title Percentage of Participants With Tumor Response by CA-125
Hide Description Response as evaluated by CA-125 levels. Response is indicated if CA-125 reduced by 50% of the baseline measure.
Time Frame Prior to each cycle of treatment. Then follow-up every three months for 2 years and then every 6 months for 3 years, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
CA-125 Evaluable patients
Arm/Group Title Paclitaxel + Placebo Paclitaxel + Pazopanib
Hide Arm/Group Description:
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
Overall Number of Participants Analyzed 32 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41
(24 to 59)
72
(55 to 85)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival
Time Frame Every cycle while patient is receiving protocol therapy. Patients monitored for survival after off therapy every 3 months for 2 years, then every 6 months, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients.
Arm/Group Title Paclitaxel + Placebo Paclitaxel + Pazopanib
Hide Arm/Group Description:
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
Overall Number of Participants Analyzed 52 54
Median (90% Confidence Interval)
Unit of Measure: months
23.3 [1] 
(17.3 to NA)
20.7
(17.0 to 22.6)
[1]
There are not enough deaths to determine the upper bound of the 90% confidence interval using the method provided by SAS.
6.Other Pre-specified Outcome
Title Single-nucleotide Polymorphisms, Assessed Using the iPLEX Assay on the Sequenome MassARRAY Platform
Hide Description Analyzed using deoxyribonucleic acid isolated from whole blood specimens.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
Time Frame Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paclitaxel + Placebo Paclitaxel + Pazopanib
Hide Arm/Group Description Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
All-Cause Mortality
Paclitaxel + Placebo Paclitaxel + Pazopanib
Affected / at Risk (%) Affected / at Risk (%)
Total   20/50 (40.00%)   23/52 (44.23%) 
Show Serious Adverse Events Hide Serious Adverse Events
Paclitaxel + Placebo Paclitaxel + Pazopanib
Affected / at Risk (%) Affected / at Risk (%)
Total   15/50 (30.00%)   22/52 (42.31%) 
Cardiac disorders     
Cardiac Disorders - Other * 1  1/50 (2.00%)  0/52 (0.00%) 
Eye disorders     
Optic Nerve Disorder * 1  0/50 (0.00%)  1/52 (1.92%) 
Gastrointestinal disorders     
Colonic Perforation * 1  0/50 (0.00%)  1/52 (1.92%) 
Vomiting * 1  3/50 (6.00%)  0/52 (0.00%) 
Small Intestinal Perforation * 1  0/50 (0.00%)  1/52 (1.92%) 
Small Intestinal Obstruction * 1  2/50 (4.00%)  2/52 (3.85%) 
Abdominal Pain * 1  2/50 (4.00%)  1/52 (1.92%) 
Mucositis Oral * 1  0/50 (0.00%)  1/52 (1.92%) 
Ileal Obstruction * 1  1/50 (2.00%)  0/52 (0.00%) 
Ascites * 1  2/50 (4.00%)  0/52 (0.00%) 
General disorders     
Pain * 1  0/50 (0.00%)  2/52 (3.85%) 
Multi-Organ Failure * 1  0/50 (0.00%)  1/52 (1.92%) 
Sudden Death Nos * 1  0/50 (0.00%)  1/52 (1.92%) 
Infections and infestations     
Skin Infection * 1  0/50 (0.00%)  1/52 (1.92%) 
Sepsis * 1  1/50 (2.00%)  0/52 (0.00%) 
Bronchial Infection * 1  0/50 (0.00%)  1/52 (1.92%) 
Appendicitis * 1  1/50 (2.00%)  0/52 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  0/50 (0.00%)  1/52 (1.92%) 
Investigations     
Neutrophil Count Decreased * 1  1/50 (2.00%)  5/52 (9.62%) 
Metabolism and nutrition disorders     
Hypophosphatemia * 1  0/50 (0.00%)  2/52 (3.85%) 
Hypokalemia * 1  0/50 (0.00%)  1/52 (1.92%) 
Musculoskeletal and connective tissue disorders     
Pain In Extremity * 1  1/50 (2.00%)  0/52 (0.00%) 
Flank Pain * 1  0/50 (0.00%)  1/52 (1.92%) 
Nervous system disorders     
Syncope * 1  1/50 (2.00%)  0/52 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  0/50 (0.00%)  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis * 1  0/50 (0.00%)  1/52 (1.92%) 
Pleural Effusion * 1  0/50 (0.00%)  1/52 (1.92%) 
Dyspnea * 1  1/50 (2.00%)  1/52 (1.92%) 
Vascular disorders     
Thromboembolic Event * 1  0/50 (0.00%)  1/52 (1.92%) 
Hypertension * 1  1/50 (2.00%)  1/52 (1.92%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paclitaxel + Placebo Paclitaxel + Pazopanib
Affected / at Risk (%) Affected / at Risk (%)
Total   50/50 (100.00%)   51/52 (98.08%) 
Blood and lymphatic system disorders     
Lymph Node Pain * 1  3/50 (6.00%)  0/52 (0.00%) 
Anemia * 1  46/50 (92.00%)  48/52 (92.31%) 
Febrile Neutropenia * 1  0/50 (0.00%)  1/52 (1.92%) 
Cardiac disorders     
Atrial Fibrillation * 1  1/50 (2.00%)  0/52 (0.00%) 
Sinus Bradycardia * 1  1/50 (2.00%)  0/52 (0.00%) 
Palpitations * 1  2/50 (4.00%)  3/52 (5.77%) 
Left Ventricular Systolic Dysfunction * 1  1/50 (2.00%)  0/52 (0.00%) 
Atrioventricular Block First Degree * 1  0/50 (0.00%)  1/52 (1.92%) 
Sinus Tachycardia * 1  3/50 (6.00%)  2/52 (3.85%) 
Chest Pain - Cardiac * 1  1/50 (2.00%)  1/52 (1.92%) 
Ear and labyrinth disorders     
Vertigo * 1  0/50 (0.00%)  1/52 (1.92%) 
Tinnitus * 1  1/50 (2.00%)  2/52 (3.85%) 
Ear Pain * 1  0/50 (0.00%)  1/52 (1.92%) 
Endocrine disorders     
Hyperparathyroidism * 1  0/50 (0.00%)  1/52 (1.92%) 
Eye disorders     
Eye Disorders - Other * 1  1/50 (2.00%)  1/52 (1.92%) 
Watering Eyes * 1  0/50 (0.00%)  3/52 (5.77%) 
Cataract * 1  1/50 (2.00%)  0/52 (0.00%) 
Conjunctivitis * 1  0/50 (0.00%)  1/52 (1.92%) 
Blurred Vision * 1  2/50 (4.00%)  3/52 (5.77%) 
Dry Eye * 1  0/50 (0.00%)  2/52 (3.85%) 
Gastrointestinal disorders     
Dysphagia * 1  0/50 (0.00%)  3/52 (5.77%) 
Duodenal Stenosis * 1  0/50 (0.00%)  1/52 (1.92%) 
Dyspepsia * 1  6/50 (12.00%)  4/52 (7.69%) 
Dry Mouth * 1  2/50 (4.00%)  4/52 (7.69%) 
Colitis * 1  0/50 (0.00%)  1/52 (1.92%) 
Constipation * 1  27/50 (54.00%)  23/52 (44.23%) 
Diarrhea * 1  15/50 (30.00%)  35/52 (67.31%) 
Vomiting * 1  10/50 (20.00%)  22/52 (42.31%) 
Bloating * 1  5/50 (10.00%)  5/52 (9.62%) 
Stomach Pain * 1  4/50 (8.00%)  4/52 (7.69%) 
Anal Hemorrhage * 1  2/50 (4.00%)  1/52 (1.92%) 
Abdominal Pain * 1  24/50 (48.00%)  21/52 (40.38%) 
Rectal Hemorrhage * 1  3/50 (6.00%)  2/52 (3.85%) 
Oral Dysesthesia * 1  0/50 (0.00%)  1/52 (1.92%) 
Mucositis Oral * 1  6/50 (12.00%)  14/52 (26.92%) 
Gastrointestinal Disorders - Other * 1  2/50 (4.00%)  0/52 (0.00%) 
Oral Hemorrhage * 1  0/50 (0.00%)  1/52 (1.92%) 
Ileus * 1  2/50 (4.00%)  0/52 (0.00%) 
Gingival Pain * 1  0/50 (0.00%)  1/52 (1.92%) 
Oral Pain * 1  2/50 (4.00%)  4/52 (7.69%) 
Oral Cavity Fistula * 1  1/50 (2.00%)  0/52 (0.00%) 
Abdominal Distension * 1  5/50 (10.00%)  3/52 (5.77%) 
Nausea * 1  30/50 (60.00%)  36/52 (69.23%) 
Gastroesophageal Reflux Disease * 1  2/50 (4.00%)  4/52 (7.69%) 
Hemorrhoidal Hemorrhage * 1  0/50 (0.00%)  1/52 (1.92%) 
Hemorrhoids * 1  1/50 (2.00%)  3/52 (5.77%) 
Esophageal Stenosis * 1  0/50 (0.00%)  1/52 (1.92%) 
Ascites * 1  1/50 (2.00%)  5/52 (9.62%) 
Toothache * 1  1/50 (2.00%)  0/52 (0.00%) 
Flatulence * 1  2/50 (4.00%)  3/52 (5.77%) 
General disorders     
Pain * 1  9/50 (18.00%)  9/52 (17.31%) 
Malaise * 1  1/50 (2.00%)  3/52 (5.77%) 
Localized Edema * 1  3/50 (6.00%)  2/52 (3.85%) 
Flu Like Symptoms * 1  2/50 (4.00%)  1/52 (1.92%) 
Non-Cardiac Chest Pain * 1  2/50 (4.00%)  2/52 (3.85%) 
Edema Limbs * 1  7/50 (14.00%)  8/52 (15.38%) 
Edema Face * 1  0/50 (0.00%)  1/52 (1.92%) 
Fatigue * 1  39/50 (78.00%)  39/52 (75.00%) 
Fever * 1  3/50 (6.00%)  5/52 (9.62%) 
Gait Disturbance * 1  1/50 (2.00%)  4/52 (7.69%) 
Chills * 1  0/50 (0.00%)  2/52 (3.85%) 
Infusion Related Reaction * 1  1/50 (2.00%)  1/52 (1.92%) 
Immune system disorders     
Allergic Reaction * 1  1/50 (2.00%)  0/52 (0.00%) 
Infections and infestations     
Upper Respiratory Infection * 1  3/50 (6.00%)  4/52 (7.69%) 
Tooth Infection * 1  1/50 (2.00%)  0/52 (0.00%) 
Vulval Infection * 1  0/50 (0.00%)  1/52 (1.92%) 
Skin Infection * 1  3/50 (6.00%)  3/52 (5.77%) 
Sinusitis * 1  1/50 (2.00%)  3/52 (5.77%) 
Sepsis * 1  1/50 (2.00%)  0/52 (0.00%) 
Nail Infection * 1  0/50 (0.00%)  1/52 (1.92%) 
Mucosal Infection * 1  1/50 (2.00%)  1/52 (1.92%) 
Lung Infection * 1  2/50 (4.00%)  0/52 (0.00%) 
Kidney Infection * 1  1/50 (2.00%)  0/52 (0.00%) 
Gum Infection * 1  1/50 (2.00%)  1/52 (1.92%) 
Urinary Tract Infection * 1  2/50 (4.00%)  5/52 (9.62%) 
Catheter Related Infection * 1  1/50 (2.00%)  1/52 (1.92%) 
Breast Infection * 1  1/50 (2.00%)  0/52 (0.00%) 
Lip Infection * 1  0/50 (0.00%)  1/52 (1.92%) 
Abdominal Infection * 1  0/50 (0.00%)  1/52 (1.92%) 
Injury, poisoning and procedural complications     
Prolapse Of Intestinal Stoma * 1  0/50 (0.00%)  1/52 (1.92%) 
Fracture * 1  0/50 (0.00%)  1/52 (1.92%) 
Fall * 1  1/50 (2.00%)  1/52 (1.92%) 
Wound Complication * 1  1/50 (2.00%)  0/52 (0.00%) 
Bruising * 1  1/50 (2.00%)  1/52 (1.92%) 
Investigations     
Investigations - Other * 1  1/50 (2.00%)  0/52 (0.00%) 
Weight Loss * 1  1/50 (2.00%)  6/52 (11.54%) 
Weight Gain * 1  2/50 (4.00%)  3/52 (5.77%) 
Serum Amylase Increased * 1  1/50 (2.00%)  0/52 (0.00%) 
Platelet Count Decreased * 1  10/50 (20.00%)  24/52 (46.15%) 
Lymphocyte Count Decreased * 1  9/50 (18.00%)  14/52 (26.92%) 
Lipase Increased * 1  1/50 (2.00%)  1/52 (1.92%) 
Inr Increased * 1  2/50 (4.00%)  1/52 (1.92%) 
Ggt Increased * 1  0/50 (0.00%)  1/52 (1.92%) 
Electrocardiogram Qt Corrected Interval Prolonged * 1  2/50 (4.00%)  1/52 (1.92%) 
Creatinine Increased * 1  5/50 (10.00%)  10/52 (19.23%) 
Cholesterol High * 1  1/50 (2.00%)  0/52 (0.00%) 
Neutrophil Count Decreased * 1  23/50 (46.00%)  43/52 (82.69%) 
Cardiac Troponin I Increased * 1  1/50 (2.00%)  0/52 (0.00%) 
Cpk Increased * 1  0/50 (0.00%)  1/52 (1.92%) 
Blood Bilirubin Increased * 1  4/50 (8.00%)  6/52 (11.54%) 
White Blood Cell Decreased * 1  35/50 (70.00%)  47/52 (90.38%) 
Aspartate Aminotransferase Increased * 1  3/50 (6.00%)  18/52 (34.62%) 
Alkaline Phosphatase Increased * 1  6/50 (12.00%)  14/52 (26.92%) 
Alanine Aminotransferase Increased * 1  7/50 (14.00%)  20/52 (38.46%) 
Activated Partial Thromboplastin Time Prolonged * 1  0/50 (0.00%)  2/52 (3.85%) 
Metabolism and nutrition disorders     
Metabolism And Nutrition Disorders - Other * 1  0/50 (0.00%)  1/52 (1.92%) 
Iron Overload * 1  0/50 (0.00%)  1/52 (1.92%) 
Hypophosphatemia * 1  5/50 (10.00%)  8/52 (15.38%) 
Hyponatremia * 1  7/50 (14.00%)  12/52 (23.08%) 
Hypomagnesemia * 1  12/50 (24.00%)  19/52 (36.54%) 
Hypokalemia * 1  11/50 (22.00%)  17/52 (32.69%) 
Hypoglycemia * 1  4/50 (8.00%)  2/52 (3.85%) 
Hypocalcemia * 1  8/50 (16.00%)  12/52 (23.08%) 
Hypoalbuminemia * 1  7/50 (14.00%)  12/52 (23.08%) 
Hyperuricemia * 1  1/50 (2.00%)  0/52 (0.00%) 
Hypertriglyceridemia * 1  1/50 (2.00%)  1/52 (1.92%) 
Hypernatremia * 1  3/50 (6.00%)  2/52 (3.85%) 
Hypermagnesemia * 1  0/50 (0.00%)  1/52 (1.92%) 
Hyperkalemia * 1  3/50 (6.00%)  4/52 (7.69%) 
Hyperglycemia * 1  17/50 (34.00%)  21/52 (40.38%) 
Hypercalcemia * 1  1/50 (2.00%)  1/52 (1.92%) 
Glucose Intolerance * 1  0/50 (0.00%)  1/52 (1.92%) 
Dehydration * 1  1/50 (2.00%)  8/52 (15.38%) 
Anorexia * 1  12/50 (24.00%)  20/52 (38.46%) 
Musculoskeletal and connective tissue disorders     
Pain In Extremity * 1  5/50 (10.00%)  2/52 (3.85%) 
Myalgia * 1  9/50 (18.00%)  14/52 (26.92%) 
Muscle Weakness Trunk * 1  0/50 (0.00%)  1/52 (1.92%) 
Muscle Weakness Lower Limb * 1  1/50 (2.00%)  1/52 (1.92%) 
Generalized Muscle Weakness * 1  2/50 (4.00%)  6/52 (11.54%) 
Flank Pain * 1  2/50 (4.00%)  0/52 (0.00%) 
Bone Pain * 1  2/50 (4.00%)  0/52 (0.00%) 
Back Pain * 1  10/50 (20.00%)  11/52 (21.15%) 
Arthritis * 1  0/50 (0.00%)  1/52 (1.92%) 
Arthralgia * 1  6/50 (12.00%)  8/52 (15.38%) 
Musculoskeletal And Connective Tissue Disorder - * 1  1/50 (2.00%)  0/52 (0.00%) 
Nervous system disorders     
Tremor * 1  1/50 (2.00%)  2/52 (3.85%) 
Transient Ischemic Attacks * 1  0/50 (0.00%)  1/52 (1.92%) 
Presyncope * 1  0/50 (0.00%)  1/52 (1.92%) 
Peripheral Sensory Neuropathy * 1  27/50 (54.00%)  27/52 (51.92%) 
Peripheral Motor Neuropathy * 1  5/50 (10.00%)  5/52 (9.62%) 
Paresthesia * 1  6/50 (12.00%)  1/52 (1.92%) 
Memory Impairment * 1  2/50 (4.00%)  1/52 (1.92%) 
Headache * 1  13/50 (26.00%)  17/52 (32.69%) 
Dysphasia * 1  0/50 (0.00%)  1/52 (1.92%) 
Dysgeusia * 1  7/50 (14.00%)  8/52 (15.38%) 
Dysesthesia * 1  1/50 (2.00%)  0/52 (0.00%) 
Dysarthria * 1  0/50 (0.00%)  1/52 (1.92%) 
Syncope * 1  1/50 (2.00%)  1/52 (1.92%) 
Dizziness * 1  6/50 (12.00%)  14/52 (26.92%) 
Concentration Impairment * 1  0/50 (0.00%)  1/52 (1.92%) 
Cognitive Disturbance * 1  1/50 (2.00%)  0/52 (0.00%) 
Psychiatric disorders     
Insomnia * 1  8/50 (16.00%)  13/52 (25.00%) 
Depression * 1  3/50 (6.00%)  9/52 (17.31%) 
Confusion * 1  1/50 (2.00%)  1/52 (1.92%) 
Anxiety * 1  9/50 (18.00%)  9/52 (17.31%) 
Renal and urinary disorders     
Urine Discoloration * 1  0/50 (0.00%)  1/52 (1.92%) 
Urinary Urgency * 1  1/50 (2.00%)  0/52 (0.00%) 
Urinary Tract Obstruction * 1  1/50 (2.00%)  1/52 (1.92%) 
Urinary Incontinence * 1  1/50 (2.00%)  2/52 (3.85%) 
Urinary Tract Pain * 1  2/50 (4.00%)  2/52 (3.85%) 
Urinary Frequency * 1  1/50 (2.00%)  1/52 (1.92%) 
Renal Calculi * 1  0/50 (0.00%)  1/52 (1.92%) 
Proteinuria * 1  1/50 (2.00%)  4/52 (7.69%) 
Hematuria * 1  1/50 (2.00%)  1/52 (1.92%) 
Cystitis Noninfective * 1  0/50 (0.00%)  1/52 (1.92%) 
Chronic Kidney Disease * 1  0/50 (0.00%)  2/52 (3.85%) 
Reproductive system and breast disorders     
Vaginal Pain * 1  0/50 (0.00%)  1/52 (1.92%) 
Vaginal Hemorrhage * 1  1/50 (2.00%)  1/52 (1.92%) 
Pelvic Pain * 1  2/50 (4.00%)  1/52 (1.92%) 
Vaginal Discharge * 1  0/50 (0.00%)  2/52 (3.85%) 
Breast Pain * 1  1/50 (2.00%)  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, Thoracic And Mediastinal Disorders - * 1  1/50 (2.00%)  0/52 (0.00%) 
Voice Alteration * 1  0/50 (0.00%)  1/52 (1.92%) 
Sore Throat * 1  1/50 (2.00%)  2/52 (3.85%) 
Respiratory Failure * 1  1/50 (2.00%)  0/52 (0.00%) 
Postnasal Drip * 1  0/50 (0.00%)  1/52 (1.92%) 
Pleural Effusion * 1  3/50 (6.00%)  1/52 (1.92%) 
Pharyngolaryngeal Pain * 1  0/50 (0.00%)  1/52 (1.92%) 
Nasal Congestion * 1  3/50 (6.00%)  6/52 (11.54%) 
Laryngeal Inflammation * 1  1/50 (2.00%)  0/52 (0.00%) 
Laryngeal Hemorrhage * 1  1/50 (2.00%)  0/52 (0.00%) 
Hoarseness * 1  0/50 (0.00%)  3/52 (5.77%) 
Epistaxis * 1  7/50 (14.00%)  13/52 (25.00%) 
Dyspnea * 1  21/50 (42.00%)  20/52 (38.46%) 
Cough * 1  11/50 (22.00%)  8/52 (15.38%) 
Wheezing * 1  1/50 (2.00%)  0/52 (0.00%) 
Bronchopulmonary Hemorrhage * 1  0/50 (0.00%)  1/52 (1.92%) 
Atelectasis * 1  0/50 (0.00%)  1/52 (1.92%) 
Allergic Rhinitis * 1  3/50 (6.00%)  3/52 (5.77%) 
Skin and subcutaneous tissue disorders     
Skin And Subcutaneous Tissue Disorders - Other * 1  2/50 (4.00%)  0/52 (0.00%) 
Urticaria * 1  0/50 (0.00%)  1/52 (1.92%) 
Skin Hyperpigmentation * 1  1/50 (2.00%)  1/52 (1.92%) 
Rash Acneiform * 1  2/50 (4.00%)  0/52 (0.00%) 
Pruritus * 1  4/50 (8.00%)  4/52 (7.69%) 
Photosensitivity * 1  1/50 (2.00%)  0/52 (0.00%) 
Palmar-Plantar Erythrodysesthesia Syndrome * 1  0/50 (0.00%)  3/52 (5.77%) 
Pain Of Skin * 1  1/50 (2.00%)  2/52 (3.85%) 
Rash Maculo-Papular * 1  9/50 (18.00%)  8/52 (15.38%) 
Skin Hypopigmentation * 1  0/50 (0.00%)  3/52 (5.77%) 
Nail Ridging * 1  1/50 (2.00%)  2/52 (3.85%) 
Nail Loss * 1  0/50 (0.00%)  4/52 (7.69%) 
Nail Discoloration * 1  4/50 (8.00%)  6/52 (11.54%) 
Erythema Multiforme * 1  1/50 (2.00%)  0/52 (0.00%) 
Dry Skin * 1  2/50 (4.00%)  2/52 (3.85%) 
Alopecia * 1  29/50 (58.00%)  24/52 (46.15%) 
Surgical and medical procedures     
Surgical And Medical Procedures - Other * 1  0/50 (0.00%)  1/52 (1.92%) 
Vascular disorders     
Thromboembolic Event * 1  2/50 (4.00%)  2/52 (3.85%) 
Lymphedema * 1  2/50 (4.00%)  1/52 (1.92%) 
Hypotension * 1  2/50 (4.00%)  3/52 (5.77%) 
Hypertension * 1  10/50 (20.00%)  29/52 (55.77%) 
Hot Flashes * 1  3/50 (6.00%)  3/52 (5.77%) 
Hematoma * 1  0/50 (0.00%)  1/52 (1.92%) 
Flushing * 1  2/50 (4.00%)  2/52 (3.85%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
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 on behalf of Michael Sill, PhD.
Organization: NRG Oncology
Phone: 716-845-1169
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01468909     History of Changes
Other Study ID Numbers: NCI-2011-03635
NCI-2011-03635 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000716028
GOG-0186J
GOG-0186J ( Other Identifier: NRG Oncology )
GOG-0186J ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: November 8, 2011
First Posted: November 10, 2011
Results First Submitted: February 8, 2019
Results First Posted: April 16, 2019
Last Update Posted: April 16, 2019