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Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT02065687
Recruitment Status : Active, not recruiting
First Posted : February 19, 2014
Results First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Endometrial Adenocarcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Endometrial Undifferentiated Carcinoma
Recurrent Uterine Corpus Carcinoma
Stage III Uterine Corpus Cancer AJCC v7
Stage IIIA Uterine Corpus Cancer AJCC v7
Stage IIIB Uterine Corpus Cancer AJCC v7
Stage IIIC Uterine Corpus Cancer AJCC v7
Stage IV Uterine Corpus Cancer AJCC v7
Stage IVA Uterine Corpus Cancer AJCC v7
Stage IVB Uterine Corpus Cancer AJCC v7
Interventions Drug: Carboplatin
Other: Laboratory Biomarker Analysis
Drug: Metformin Hydrochloride
Drug: Paclitaxel
Other: Placebo Administration
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Enrollment 469
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Hide Arm/Group Description Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 234 235
Completed 234 235
Not Completed 0 0
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo) Total
Hide Arm/Group Description Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 234 235 469
Hide Baseline Analysis Population Description
All patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 234 participants 235 participants 469 participants
65  (9) 64  (9) 65  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 235 participants 469 participants
Female
234
 100.0%
235
 100.0%
469
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 235 participants 469 participants
Hispanic or Latino
12
   5.1%
9
   3.8%
21
   4.5%
Not Hispanic or Latino
214
  91.5%
223
  94.9%
437
  93.2%
Unknown or Not Reported
8
   3.4%
3
   1.3%
11
   2.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 235 participants 469 participants
American Indian or Alaska Native
3
   1.3%
2
   0.9%
5
   1.1%
Asian
10
   4.3%
3
   1.3%
13
   2.8%
Native Hawaiian or Other Pacific Islander
1
   0.4%
0
   0.0%
1
   0.2%
Black or African American
39
  16.7%
22
   9.4%
61
  13.0%
White
171
  73.1%
201
  85.5%
372
  79.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
10
   4.3%
7
   3.0%
17
   3.6%
1.Primary Outcome
Title Progression-free Survival (PFS) (Phase II)
Hide Description Time until disease progression, death, or date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.
Time Frame From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Hide Arm/Group Description:
Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 234 235
Median (95% Confidence Interval)
Unit of Measure: Months
9.0
(8.4 to 10.5)
8.5
(8.0 to 10.3)
2.Primary Outcome
Title Overall Survival (OS) (Phase II and III)
Hide Description The observed length of life from randomization into the study to death or the date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.
Time Frame From date of study entry to time of death or the date of last contact, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients.
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Hide Arm/Group Description:
Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 234 235
Median (95% Confidence Interval)
Unit of Measure: Months
34.6
(28.0 to 50.1)
30.4
(24.6 to 37.8)
3.Secondary Outcome
Title Proportion of Patients Responding to Therapy
Hide Description The proportion of patients who had a response (complete or partial) by RECIST 1.1. Measurable disease is defined by RECIST (version 1.1). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI.
Time Frame During study treatment, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Hide Arm/Group Description:
Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 164 171
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
61.6
(53.7 to 69.1)
60.2
(52.5 to 67.6)
4.Secondary Outcome
Title Duration of Response by Treatment
Hide Description Duration of response until disease progression, death, or date last seen among patients who responded.
Time Frame From the date of response to disease progression, death, or date last seen assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who responded
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Hide Arm/Group Description:
Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 101 103
Median (95% Confidence Interval)
Unit of Measure: Months
8.0
(6.3 to 9.4)
8.0
(6.2 to 10.3)
5.Secondary Outcome
Title Overall Survival (OS) (Phase II)
Hide Description The observed length of life from randomization into the study to death or the date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.
Time Frame From date of study entry to time of death or the date of last contact, assessed up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Hide Arm/Group Description:
Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 234 235
Median (95% Confidence Interval)
Unit of Measure: Months
34.6
(28.0 to 50.1)
30.4
(24.6 to 37.8)
6.Secondary Outcome
Title Progression Free Survival (PFS) (Phase III)
Hide Description Time until disease progression, death, or date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.
Time Frame From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients.
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Hide Arm/Group Description:
Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 234 235
Median (95% Confidence Interval)
Unit of Measure: Months
9.0
(8.4 to 10.5)
8.5
(8.0 to 10.3)
7.Secondary Outcome
Title Number of Participants With Grade 3 or Higher Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4
Hide Description Toxicities will be assessed by organ or organ system. For each category of toxicity, each patient will be evaluated by the worst grade experienced during the course of therapy. Data will be summarized by frequency and severity according to the regimen administered. The number of patients with a grade three or greater adverse event will be reported (by system organ class).
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients.
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Hide Arm/Group Description:
Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 234 235
Measure Type: Count of Participants
Unit of Measure: Participants
Blood and lymphatic system disorders
23
   9.8%
17
   7.2%
Cardiac disorders
2
   0.9%
2
   0.9%
Ear and labyrinth disorders
1
   0.4%
0
   0.0%
Endocrine disorders
0
   0.0%
0
   0.0%
Eye disorders
0
   0.0%
0
   0.0%
Gastrointestinal disorders
17
   7.3%
10
   4.3%
General disorders administration site conditions
5
   2.1%
6
   2.6%
Immune system disorders
0
   0.0%
1
   0.4%
Infections and infestations
14
   6.0%
10
   4.3%
Injury, poisoning and procedural complications
2
   0.9%
6
   2.6%
Investigations
38
  16.2%
28
  11.9%
Metabolism and Nutrition Disorders
8
   3.4%
18
   7.7%
Musculoskeletal and connective tissue disorders
1
   0.4%
3
   1.3%
Neoplasms benign, malignant and unspecified
1
   0.4%
0
   0.0%
Nervous system disorders
8
   3.4%
9
   3.8%
Psychiatric disorders
0
   0.0%
2
   0.9%
Renal and urinary disorders
1
   0.4%
5
   2.1%
Reproductive system and breast disorders
1
   0.4%
0
   0.0%
Respiratory, thoracic and mediastinal disorders
7
   3.0%
4
   1.7%
Skin and subcutaneous tissue disorders
2
   0.9%
1
   0.4%
Vascular disorders
10
   4.3%
18
   7.7%
8.Secondary Outcome
Title Level of Obesity
Hide Description Obesity will be quantitative assessed by body mass index (BMI) and will be assessed for its predictive and prognostic significance. The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Hide Arm/Group Description:
Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 234 235
Measure Type: Number
Unit of Measure: proportion of participants obese
0.4957 0.4979
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride), Arm II (Paclitaxel, Carboplatin, Placebo)
Comments The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model. Historical data indicate that approximately 50% of people are obese (BMI>=30). For the purposes of examining the relationship, we will classify patients into two levels (high versus low) at the median BMI, which will increase the likelihood of detecting an interaction between metformin treatment and obesity.
Type of Statistical Test Equivalence
Comments The null hypothesis is that there is no relationship between BMI and metformin treatment (i.e. the parameter associated with the interaction term of BMI * treatment is equal to 0).
Statistical Test of Hypothesis P-Value 0.9482
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value -0.01787
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27472
Estimation Comments [Not Specified]
9.Other Pre-specified Outcome
Title Metabolic Factor Levels
Hide Description Hip-to-waist ratio, diabetes status, hemoglobin A1c, fasting insulin glucose levels, and homeostatic model assessment scores will be assessed for their predictive and prognostic significance. Variables will be analyzed as continuous covariates (or as appropriate with transformations such as the logarithm) with Cox models or logistic regression.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Incidence of PIK3 Mutations/Amplifications
Hide Description PIK3CA mutations/amplifications and PIK3R1/PIK3R2 mutations will be examined for prognostic and predictive significance.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Expression of MATE 2
Hide Description Expression will be examined by immunohistochemistry with intensity of staining and the percentage of cells staining positive. From these statistics, an H-score will be calculated. Expression will be further dichotomized as high expression and low expression at the median to maximize the power of the study.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Levels of Key Targets of the Metformin/mTOR Signaling Pathway
Hide Description Levels before and after treatment will be assessed for their predictive and prognostic significance.
Time Frame Up to 5 years
Outcome Measure Data Not Reported
Time Frame Patients are followed for the occurrence of adverse events for five years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Hide Arm/Group Description Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   95/234 (40.60%)   95/235 (40.43%) 
Hide Serious Adverse Events
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   46/234 (19.66%)   53/235 (22.55%) 
Blood and lymphatic system disorders     
Anemia * 1  1/234 (0.43%)  1/235 (0.43%) 
Febrile Neutropenia * 1  2/234 (0.85%)  3/235 (1.28%) 
Cardiac disorders     
Atrial Fibrillation * 1  1/234 (0.43%)  0/235 (0.00%) 
Myocardial Infarction * 1  0/234 (0.00%)  1/235 (0.43%) 
Gastrointestinal disorders     
Colonic Perforation * 1  1/234 (0.43%)  0/235 (0.00%) 
Colitis * 1  1/234 (0.43%)  0/235 (0.00%) 
Diarrhea * 1  0/234 (0.00%)  1/235 (0.43%) 
Vomiting * 1  1/234 (0.43%)  2/235 (0.85%) 
Abdominal Pain * 1  1/234 (0.43%)  1/235 (0.43%) 
Nausea * 1  2/234 (0.85%)  1/235 (0.43%) 
Ascites * 1  1/234 (0.43%)  0/235 (0.00%) 
General disorders     
Multi-Organ Failure * 1  0/234 (0.00%)  1/235 (0.43%) 
Infusion Site Extravasation * 1  0/234 (0.00%)  1/235 (0.43%) 
Non-Cardiac Chest Pain * 1  0/234 (0.00%)  1/235 (0.43%) 
Fatigue * 1  1/234 (0.43%)  0/235 (0.00%) 
Fever * 1  0/234 (0.00%)  2/235 (0.85%) 
Infusion Related Reaction * 1  2/234 (0.85%)  0/235 (0.00%) 
Immune system disorders     
Anaphylaxis * 1  0/234 (0.00%)  1/235 (0.43%) 
Allergic Reaction * 1  0/234 (0.00%)  1/235 (0.43%) 
Infections and infestations     
Infections And Infestations - Other * 1  0/234 (0.00%)  1/235 (0.43%) 
Uterine Infection * 1  1/234 (0.43%)  0/235 (0.00%) 
Soft Tissue Infection * 1  1/234 (0.43%)  0/235 (0.00%) 
Skin Infection * 1  2/234 (0.85%)  0/235 (0.00%) 
Sepsis * 1  3/234 (1.28%)  5/235 (2.13%) 
Lung Infection * 1  4/234 (1.71%)  1/235 (0.43%) 
Device Related Infection * 1  0/234 (0.00%)  1/235 (0.43%) 
Urinary Tract Infection * 1  2/234 (0.85%)  1/235 (0.43%) 
Catheter Related Infection * 1  1/234 (0.43%)  1/235 (0.43%) 
Bronchial Infection * 1  1/234 (0.43%)  0/235 (0.00%) 
Biliary Tract Infection * 1  0/234 (0.00%)  1/235 (0.43%) 
Appendicitis * 1  1/234 (0.43%)  0/235 (0.00%) 
Abdominal Infection * 1  0/234 (0.00%)  1/235 (0.43%) 
Injury, poisoning and procedural complications     
Wound Dehiscence * 1  1/234 (0.43%)  0/235 (0.00%) 
Hip Fracture * 1  1/234 (0.43%)  0/235 (0.00%) 
Fracture * 1  0/234 (0.00%)  1/235 (0.43%) 
Fall * 1  0/234 (0.00%)  1/235 (0.43%) 
Investigations     
Weight Loss * 1  2/234 (0.85%)  0/235 (0.00%) 
Creatinine Increased * 1  0/234 (0.00%)  1/235 (0.43%) 
Neutrophil Count Decreased * 1  1/234 (0.43%)  1/235 (0.43%) 
Blood Bilirubin Increased * 1  0/234 (0.00%)  1/235 (0.43%) 
Metabolism and nutrition disorders     
Hyponatremia * 1  1/234 (0.43%)  0/235 (0.00%) 
Hypokalemia * 1  0/234 (0.00%)  2/235 (0.85%) 
Hypocalcemia * 1  0/234 (0.00%)  1/235 (0.43%) 
Hypercalcemia * 1  0/234 (0.00%)  2/235 (0.85%) 
Dehydration * 1  0/234 (0.00%)  2/235 (0.85%) 
Musculoskeletal and connective tissue disorders     
Bone Pain * 1  0/234 (0.00%)  1/235 (0.43%) 
Back Pain * 1  0/234 (0.00%)  1/235 (0.43%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms Benign, Malignant And Unspecified (Incl * 1  0/234 (0.00%)  3/235 (1.28%) 
Leukemia Secondary To Oncology Chemotherapy * 1  1/234 (0.43%)  0/235 (0.00%) 
Nervous system disorders     
Stroke * 1  0/234 (0.00%)  1/235 (0.43%) 
Peripheral Sensory Neuropathy * 1  0/234 (0.00%)  1/235 (0.43%) 
Peripheral Motor Neuropathy * 1  1/234 (0.43%)  0/235 (0.00%) 
Neuralgia * 1  1/234 (0.43%)  0/235 (0.00%) 
Ischemia Cerebrovascular * 1  1/234 (0.43%)  0/235 (0.00%) 
Intracranial Hemorrhage * 1  0/234 (0.00%)  1/235 (0.43%) 
Headache * 1  0/234 (0.00%)  2/235 (0.85%) 
Syncope * 1  3/234 (1.28%)  0/235 (0.00%) 
Dizziness * 1  2/234 (0.85%)  0/235 (0.00%) 
Psychiatric disorders     
Psychosis * 1  1/234 (0.43%)  0/235 (0.00%) 
Renal and urinary disorders     
Bladder Perforation * 1  1/234 (0.43%)  0/235 (0.00%) 
Acute Kidney Injury * 1  2/234 (0.85%)  1/235 (0.43%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, Thoracic And Mediastinal Disorders - * 1  1/234 (0.43%)  0/235 (0.00%) 
Respiratory Failure * 1  0/234 (0.00%)  1/235 (0.43%) 
Pleural Effusion * 1  1/234 (0.43%)  0/235 (0.00%) 
Dyspnea * 1  0/234 (0.00%)  3/235 (1.28%) 
Adult Respiratory Distress Syndrome * 1  1/234 (0.43%)  0/235 (0.00%) 
Vascular disorders     
Thromboembolic Event * 1  4/234 (1.71%)  6/235 (2.55%) 
Hypotension * 1  0/234 (0.00%)  1/235 (0.43%) 
Hypertension * 1  0/234 (0.00%)  2/235 (0.85%) 
Hematoma * 1  1/234 (0.43%)  0/235 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) Arm II (Paclitaxel, Carboplatin, Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   222/234 (94.87%)   222/235 (94.47%) 
Blood and lymphatic system disorders     
Thrombotic Thrombocytopenic Purpura * 1  1/234 (0.43%)  0/235 (0.00%) 
Lymph Node Pain * 1  1/234 (0.43%)  1/235 (0.43%) 
Leukocytosis * 1  2/234 (0.85%)  1/235 (0.43%) 
Anemia * 1  168/234 (71.79%)  154/235 (65.53%) 
Febrile Neutropenia * 1  9/234 (3.85%)  5/235 (2.13%) 
Cardiac disorders     
Atrial Fibrillation * 1  3/234 (1.28%)  2/235 (0.85%) 
Ventricular Tachycardia * 1  0/234 (0.00%)  1/235 (0.43%) 
Supraventricular Tachycardia * 1  0/234 (0.00%)  1/235 (0.43%) 
Palpitations * 1  9/234 (3.85%)  13/235 (5.53%) 
Myocardial Infarction * 1  0/234 (0.00%)  1/235 (0.43%) 
Heart Failure * 1  1/234 (0.43%)  0/235 (0.00%) 
Restrictive Cardiomyopathy * 1  1/234 (0.43%)  0/235 (0.00%) 
Ventricular Arrhythmia * 1  0/234 (0.00%)  1/235 (0.43%) 
Sinus Tachycardia * 1  7/234 (2.99%)  7/235 (2.98%) 
Chest Pain - Cardiac * 1  3/234 (1.28%)  1/235 (0.43%) 
Ear and labyrinth disorders     
Middle Ear Inflammation * 1  0/234 (0.00%)  1/235 (0.43%) 
Vertigo * 1  1/234 (0.43%)  1/235 (0.43%) 
Tinnitus * 1  8/234 (3.42%)  16/235 (6.81%) 
Hearing Impaired * 1  5/234 (2.14%)  5/235 (2.13%) 
Vestibular Disorder * 1  0/234 (0.00%)  1/235 (0.43%) 
Ear Pain * 1  3/234 (1.28%)  3/235 (1.28%) 
Endocrine disorders     
Hypothyroidism * 1  0/234 (0.00%)  4/235 (1.70%) 
Hyperthyroidism * 1  1/234 (0.43%)  0/235 (0.00%) 
Eye disorders     
Uveitis * 1  0/234 (0.00%)  1/235 (0.43%) 
Watering Eyes * 1  1/234 (0.43%)  2/235 (0.85%) 
Flashing Lights * 1  2/234 (0.85%)  0/235 (0.00%) 
Cataract * 1  2/234 (0.85%)  2/235 (0.85%) 
Photophobia * 1  1/234 (0.43%)  0/235 (0.00%) 
Conjunctivitis * 1  1/234 (0.43%)  0/235 (0.00%) 
Retinopathy * 1  0/234 (0.00%)  1/235 (0.43%) 
Blurred Vision * 1  23/234 (9.83%)  21/235 (8.94%) 
Dry Eye * 1  2/234 (0.85%)  3/235 (1.28%) 
Floaters * 1  3/234 (1.28%)  1/235 (0.43%) 
Gastrointestinal disorders     
Dysphagia * 1  8/234 (3.42%)  5/235 (2.13%) 
Dyspepsia * 1  18/234 (7.69%)  18/235 (7.66%) 
Dry Mouth * 1  6/234 (2.56%)  4/235 (1.70%) 
Colonic Perforation * 1  1/234 (0.43%)  0/235 (0.00%) 
Colonic Fistula * 1  0/234 (0.00%)  1/235 (0.43%) 
Colitis * 1  2/234 (0.85%)  1/235 (0.43%) 
Constipation * 1  100/234 (42.74%)  111/235 (47.23%) 
Diarrhea * 1  133/234 (56.84%)  79/235 (33.62%) 
Cheilitis * 1  1/234 (0.43%)  1/235 (0.43%) 
Vomiting * 1  75/234 (32.05%)  62/235 (26.38%) 
Bloating * 1  9/234 (3.85%)  11/235 (4.68%) 
Small Intestinal Perforation * 1  0/234 (0.00%)  1/235 (0.43%) 
Stomach Pain * 1  5/234 (2.14%)  2/235 (0.85%) 
Small Intestinal Obstruction * 1  1/234 (0.43%)  2/235 (0.85%) 
Anal Hemorrhage * 1  2/234 (0.85%)  1/235 (0.43%) 
Rectal Fistula * 1  1/234 (0.43%)  0/235 (0.00%) 
Abdominal Pain * 1  57/234 (24.36%)  58/235 (24.68%) 
Rectal Hemorrhage * 1  4/234 (1.71%)  5/235 (2.13%) 
Oral Dysesthesia * 1  0/234 (0.00%)  2/235 (0.85%) 
Mucositis Oral * 1  21/234 (8.97%)  27/235 (11.49%) 
Lower Gastrointestinal Hemorrhage * 1  1/234 (0.43%)  0/235 (0.00%) 
Ileal Obstruction * 1  1/234 (0.43%)  0/235 (0.00%) 
Intra-Abdominal Hemorrhage * 1  0/234 (0.00%)  1/235 (0.43%) 
Gastrointestinal Pain * 1  1/234 (0.43%)  0/235 (0.00%) 
Oral Pain * 1  1/234 (0.43%)  4/235 (1.70%) 
Abdominal Distension * 1  5/234 (2.14%)  7/235 (2.98%) 
Nausea * 1  126/234 (53.85%)  125/235 (53.19%) 
Gastroesophageal Reflux Disease * 1  16/234 (6.84%)  11/235 (4.68%) 
Rectal Pain * 1  2/234 (0.85%)  0/235 (0.00%) 
Esophageal Ulcer * 1  0/234 (0.00%)  1/235 (0.43%) 
Fecal Incontinence * 1  1/234 (0.43%)  3/235 (1.28%) 
Hemorrhoidal Hemorrhage * 1  0/234 (0.00%)  1/235 (0.43%) 
Hemorrhoids * 1  7/234 (2.99%)  2/235 (0.85%) 
Ascites * 1  6/234 (2.56%)  4/235 (1.70%) 
Toothache * 1  3/234 (1.28%)  3/235 (1.28%) 
Dental Caries * 1  1/234 (0.43%)  0/235 (0.00%) 
Flatulence * 1  5/234 (2.14%)  5/235 (2.13%) 
Gastritis * 1  0/234 (0.00%)  2/235 (0.85%) 
General disorders     
General Disorders And Administration Site Conditio * 1  0/234 (0.00%)  1/235 (0.43%) 
Pain * 1  33/234 (14.10%)  27/235 (11.49%) 
Malaise * 1  4/234 (1.71%)  4/235 (1.70%) 
Localized Edema * 1  3/234 (1.28%)  5/235 (2.13%) 
Injection Site Reaction * 1  2/234 (0.85%)  0/235 (0.00%) 
Infusion Site Extravasation * 1  3/234 (1.28%)  2/235 (0.85%) 
Flu Like Symptoms * 1  8/234 (3.42%)  3/235 (1.28%) 
Edema Trunk * 1  1/234 (0.43%)  4/235 (1.70%) 
Non-Cardiac Chest Pain * 1  9/234 (3.85%)  12/235 (5.11%) 
Edema Limbs * 1  45/234 (19.23%)  37/235 (15.74%) 
Edema Face * 1  1/234 (0.43%)  2/235 (0.85%) 
Fatigue * 1  174/234 (74.36%)  151/235 (64.26%) 
Fever * 1  14/234 (5.98%)  15/235 (6.38%) 
Gait Disturbance * 1  6/234 (2.56%)  3/235 (1.28%) 
Chills * 1  6/234 (2.56%)  14/235 (5.96%) 
Infusion Related Reaction * 1  17/234 (7.26%)  16/235 (6.81%) 
Immune system disorders     
Anaphylaxis * 1  0/234 (0.00%)  1/235 (0.43%) 
Allergic Reaction * 1  14/234 (5.98%)  12/235 (5.11%) 
Autoimmune Disorder * 1  0/234 (0.00%)  1/235 (0.43%) 
Infections and infestations     
Infections And Infestations - Other * 1  1/234 (0.43%)  0/235 (0.00%) 
Wound Infection * 1  2/234 (0.85%)  1/235 (0.43%) 
Upper Respiratory Infection * 1  9/234 (3.85%)  9/235 (3.83%) 
Tooth Infection * 1  3/234 (1.28%)  2/235 (0.85%) 
Vulval Infection * 1  0/234 (0.00%)  1/235 (0.43%) 
Soft Tissue Infection * 1  2/234 (0.85%)  0/235 (0.00%) 
Skin Infection * 1  7/234 (2.99%)  5/235 (2.13%) 
Sinusitis * 1  3/234 (1.28%)  5/235 (2.13%) 
Sepsis * 1  7/234 (2.99%)  5/235 (2.13%) 
Rhinitis Infective * 1  0/234 (0.00%)  1/235 (0.43%) 
Rash Pustular * 1  1/234 (0.43%)  0/235 (0.00%) 
Otitis Media * 1  1/234 (0.43%)  1/235 (0.43%) 
Papulopustular Rash * 1  2/234 (0.85%)  2/235 (0.85%) 
Otitis Externa * 1  1/234 (0.43%)  0/235 (0.00%) 
Nail Infection * 1  0/234 (0.00%)  1/235 (0.43%) 
Mucosal Infection * 1  0/234 (0.00%)  1/235 (0.43%) 
Lung Infection * 1  3/234 (1.28%)  4/235 (1.70%) 
Kidney Infection * 1  0/234 (0.00%)  1/235 (0.43%) 
Eye Infection * 1  0/234 (0.00%)  1/235 (0.43%) 
Conjunctivitis Infective * 1  1/234 (0.43%)  1/235 (0.43%) 
Vaginal Infection * 1  4/234 (1.71%)  2/235 (0.85%) 
Urinary Tract Infection * 1  28/234 (11.97%)  21/235 (8.94%) 
Catheter Related Infection * 1  1/234 (0.43%)  1/235 (0.43%) 
Bronchial Infection * 1  2/234 (0.85%)  1/235 (0.43%) 
Enterocolitis Infectious * 1  0/234 (0.00%)  1/235 (0.43%) 
Biliary Tract Infection * 1  0/234 (0.00%)  1/235 (0.43%) 
Appendicitis * 1  1/234 (0.43%)  0/235 (0.00%) 
Abdominal Infection * 1  0/234 (0.00%)  1/235 (0.43%) 
Injury, poisoning and procedural complications     
Wound Dehiscence * 1  4/234 (1.71%)  1/235 (0.43%) 
Vascular Access Complication * 1  0/234 (0.00%)  1/235 (0.43%) 
Spinal Fracture * 1  0/234 (0.00%)  2/235 (0.85%) 
Hip Fracture * 1  1/234 (0.43%)  0/235 (0.00%) 
Fracture * 1  3/234 (1.28%)  1/235 (0.43%) 
Fall * 1  11/234 (4.70%)  7/235 (2.98%) 
Wound Complication * 1  2/234 (0.85%)  3/235 (1.28%) 
Dermatitis Radiation * 1  0/234 (0.00%)  1/235 (0.43%) 
Bruising * 1  10/234 (4.27%)  16/235 (6.81%) 
Ankle Fracture * 1  1/234 (0.43%)  2/235 (0.85%) 
Investigations     
Weight Loss * 1  27/234 (11.54%)  22/235 (9.36%) 
Weight Gain * 1  3/234 (1.28%)  9/235 (3.83%) 
Platelet Count Decreased * 1  90/234 (38.46%)  85/235 (36.17%) 
Lymphocyte Count Increased * 1  1/234 (0.43%)  1/235 (0.43%) 
Lymphocyte Count Decreased * 1  19/234 (8.12%)  19/235 (8.09%) 
Inr Increased * 1  0/234 (0.00%)  1/235 (0.43%) 
Hemoglobin Increased * 1  0/234 (0.00%)  1/235 (0.43%) 
Ggt Increased * 1  1/234 (0.43%)  0/235 (0.00%) 
Creatinine Increased * 1  25/234 (10.68%)  25/235 (10.64%) 
Cholesterol High * 1  2/234 (0.85%)  1/235 (0.43%) 
Neutrophil Count Decreased * 1  117/234 (50.00%)  119/235 (50.64%) 
Blood Bilirubin Increased * 1  5/234 (2.14%)  4/235 (1.70%) 
White Blood Cell Decreased * 1  134/234 (57.26%)  133/235 (56.60%) 
Aspartate Aminotransferase Increased * 1  19/234 (8.12%)  25/235 (10.64%) 
Alkaline Phosphatase Increased * 1  27/234 (11.54%)  24/235 (10.21%) 
Alanine Aminotransferase Increased * 1  27/234 (11.54%)  24/235 (10.21%) 
Activated Partial Thromboplastin Time Prolonged * 1  1/234 (0.43%)  0/235 (0.00%) 
Metabolism and nutrition disorders     
Obesity * 1  0/234 (0.00%)  1/235 (0.43%) 
Hypophosphatemia * 1  3/234 (1.28%)  6/235 (2.55%) 
Hyponatremia * 1  29/234 (12.39%)  32/235 (13.62%) 
Hypomagnesemia * 1  49/234 (20.94%)  32/235 (13.62%) 
Hypokalemia * 1  34/234 (14.53%)  35/235 (14.89%) 
Hypoglycemia * 1  4/234 (1.71%)  4/235 (1.70%) 
Hypocalcemia * 1  17/234 (7.26%)  14/235 (5.96%) 
Hypoalbuminemia * 1  28/234 (11.97%)  39/235 (16.60%) 
Hyperuricemia * 1  0/234 (0.00%)  1/235 (0.43%) 
Hypertriglyceridemia * 1  1/234 (0.43%)  0/235 (0.00%) 
Hypernatremia * 1  7/234 (2.99%)  4/235 (1.70%) 
Hypermagnesemia * 1  1/234 (0.43%)  0/235 (0.00%) 
Hyperkalemia * 1  2/234 (0.85%)  6/235 (2.55%) 
Hyperglycemia * 1  56/234 (23.93%)  46/235 (19.57%) 
Hypercalcemia * 1  12/234 (5.13%)  14/235 (5.96%) 
Glucose Intolerance * 1  1/234 (0.43%)  2/235 (0.85%) 
Dehydration * 1  14/234 (5.98%)  18/235 (7.66%) 
Anorexia * 1  71/234 (30.34%)  65/235 (27.66%) 
Musculoskeletal and connective tissue disorders     
Pain In Extremity * 1  36/234 (15.38%)  42/235 (17.87%) 
Osteoporosis * 1  0/234 (0.00%)  1/235 (0.43%) 
Neck Pain * 1  4/234 (1.71%)  3/235 (1.28%) 
Myalgia * 1  45/234 (19.23%)  48/235 (20.43%) 
Muscle Weakness Upper Limb * 1  1/234 (0.43%)  3/235 (1.28%) 
Muscle Weakness Lower Limb * 1  4/234 (1.71%)  9/235 (3.83%) 
Muscle Weakness Left-Sided * 1  1/234 (0.43%)  0/235 (0.00%) 
Joint Range Of Motion Decreased Lumbar Spine * 1  0/234 (0.00%)  1/235 (0.43%) 
Joint Range Of Motion Decreased * 1  0/234 (0.00%)  1/235 (0.43%) 
Generalized Muscle Weakness * 1  24/234 (10.26%)  24/235 (10.21%) 
Flank Pain * 1  2/234 (0.85%)  3/235 (1.28%) 
Chest Wall Pain * 1  0/234 (0.00%)  2/235 (0.85%) 
Buttock Pain * 1  1/234 (0.43%)  3/235 (1.28%) 
Bone Pain * 1  24/234 (10.26%)  24/235 (10.21%) 
Back Pain * 1  30/234 (12.82%)  36/235 (15.32%) 
Arthritis * 1  3/234 (1.28%)  7/235 (2.98%) 
Arthralgia * 1  43/234 (18.38%)  55/235 (23.40%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor Pain * 1  3/234 (1.28%)  1/235 (0.43%) 
Leukemia Secondary To Oncology Chemotherapy * 1  1/234 (0.43%)  0/235 (0.00%) 
Nervous system disorders     
Tremor * 1  4/234 (1.71%)  2/235 (0.85%) 
Transient Ischemic Attacks * 1  0/234 (0.00%)  1/235 (0.43%) 
Stroke * 1  0/234 (0.00%)  1/235 (0.43%) 
Seizure * 1  2/234 (0.85%)  0/235 (0.00%) 
Presyncope * 1  1/234 (0.43%)  3/235 (1.28%) 
Peripheral Sensory Neuropathy * 1  145/234 (61.97%)  157/235 (66.81%) 
Peripheral Motor Neuropathy * 1  14/234 (5.98%)  16/235 (6.81%) 
Paresthesia * 1  20/234 (8.55%)  9/235 (3.83%) 
Neuralgia * 1  1/234 (0.43%)  1/235 (0.43%) 
Memory Impairment * 1  9/234 (3.85%)  10/235 (4.26%) 
Lethargy * 1  3/234 (1.28%)  1/235 (0.43%) 
Ischemia Cerebrovascular * 1  1/234 (0.43%)  0/235 (0.00%) 
Movements Involuntary * 1  1/234 (0.43%)  1/235 (0.43%) 
Intracranial Hemorrhage * 1  1/234 (0.43%)  1/235 (0.43%) 
Headache * 1  44/234 (18.80%)  33/235 (14.04%) 
Facial Muscle Weakness * 1  1/234 (0.43%)  0/235 (0.00%) 
Encephalopathy * 1  0/234 (0.00%)  1/235 (0.43%) 
Dysphasia * 1  1/234 (0.43%)  0/235 (0.00%) 
Dysgeusia * 1  27/234 (11.54%)  25/235 (10.64%) 
Dysesthesia * 1  0/234 (0.00%)  2/235 (0.85%) 
Dysarthria * 1  1/234 (0.43%)  2/235 (0.85%) 
Syncope * 1  6/234 (2.56%)  0/235 (0.00%) 
Dizziness * 1  33/234 (14.10%)  37/235 (15.74%) 
Depressed Level Of Consciousness * 1  0/234 (0.00%)  1/235 (0.43%) 
Concentration Impairment * 1  1/234 (0.43%)  1/235 (0.43%) 
Cognitive Disturbance * 1  4/234 (1.71%)  1/235 (0.43%) 
Ataxia * 1  1/234 (0.43%)  0/235 (0.00%) 
Akathisia * 1  1/234 (0.43%)  3/235 (1.28%) 
Psychiatric disorders     
Psychosis * 1  1/234 (0.43%)  0/235 (0.00%) 
Personality Change * 1  1/234 (0.43%)  3/235 (1.28%) 
Restlessness * 1  0/234 (0.00%)  2/235 (0.85%) 
Insomnia * 1  36/234 (15.38%)  42/235 (17.87%) 
Hallucinations * 1  1/234 (0.43%)  1/235 (0.43%) 
Depression * 1  30/234 (12.82%)  30/235 (12.77%) 
Delirium * 1  0/234 (0.00%)  2/235 (0.85%) 
Confusion * 1  3/234 (1.28%)  8/235 (3.40%) 
Anxiety * 1  24/234 (10.26%)  38/235 (16.17%) 
Agitation * 1  3/234 (1.28%)  6/235 (2.55%) 
Renal and urinary disorders     
Renal And Urinary Disorders - Other * 1  0/234 (0.00%)  1/235 (0.43%) 
Urinary Urgency * 1  7/234 (2.99%)  5/235 (2.13%) 
Urinary Tract Obstruction * 1  0/234 (0.00%)  2/235 (0.85%) 
Urinary Retention * 1  1/234 (0.43%)  2/235 (0.85%) 
Urinary Incontinence * 1  12/234 (5.13%)  19/235 (8.09%) 
Urinary Tract Pain * 1  14/234 (5.98%)  15/235 (6.38%) 
Urinary Frequency * 1  19/234 (8.12%)  14/235 (5.96%) 
Urinary Fistula * 1  1/234 (0.43%)  0/235 (0.00%) 
Renal Calculi * 1  0/234 (0.00%)  2/235 (0.85%) 
Proteinuria * 1  5/234 (2.14%)  3/235 (1.28%) 
Hematuria * 1  7/234 (2.99%)  14/235 (5.96%) 
Cystitis Noninfective * 1  1/234 (0.43%)  2/235 (0.85%) 
Chronic Kidney Disease * 1  1/234 (0.43%)  2/235 (0.85%) 
Bladder Spasm * 1  1/234 (0.43%)  1/235 (0.43%) 
Bladder Perforation * 1  1/234 (0.43%)  0/235 (0.00%) 
Acute Kidney Injury * 1  2/234 (0.85%)  1/235 (0.43%) 
Reproductive system and breast disorders     
Vaginal Perforation * 1  1/234 (0.43%)  0/235 (0.00%) 
Vaginal Pain * 1  3/234 (1.28%)  2/235 (0.85%) 
Vaginal Hemorrhage * 1  11/234 (4.70%)  19/235 (8.09%) 
Vaginal Dryness * 1  3/234 (1.28%)  2/235 (0.85%) 
Uterine Hemorrhage * 1  1/234 (0.43%)  0/235 (0.00%) 
Perineal Pain * 1  1/234 (0.43%)  0/235 (0.00%) 
Pelvic Pain * 1  8/234 (3.42%)  12/235 (5.11%) 
Menorrhagia * 1  1/234 (0.43%)  0/235 (0.00%) 
Vaginal Discharge * 1  11/234 (4.70%)  11/235 (4.68%) 
Vaginal Inflammation * 1  2/234 (0.85%)  0/235 (0.00%) 
Breast Pain * 1  1/234 (0.43%)  1/235 (0.43%) 
Respiratory, thoracic and mediastinal disorders     
Voice Alteration * 1  2/234 (0.85%)  1/235 (0.43%) 
Sore Throat * 1  8/234 (3.42%)  6/235 (2.55%) 
Sneezing * 1  0/234 (0.00%)  1/235 (0.43%) 
Respiratory Failure * 1  0/234 (0.00%)  2/235 (0.85%) 
Postnasal Drip * 1  4/234 (1.71%)  2/235 (0.85%) 
Pneumothorax * 1  1/234 (0.43%)  1/235 (0.43%) 
Pneumonitis * 1  0/234 (0.00%)  1/235 (0.43%) 
Pleural Effusion * 1  2/234 (0.85%)  2/235 (0.85%) 
Nasal Congestion * 1  10/234 (4.27%)  4/235 (1.70%) 
Pleuritic Pain * 1  1/234 (0.43%)  0/235 (0.00%) 
Productive Cough * 1  5/234 (2.14%)  4/235 (1.70%) 
Hypoxia * 1  2/234 (0.85%)  1/235 (0.43%) 
Hoarseness * 1  3/234 (1.28%)  2/235 (0.85%) 
Sleep Apnea * 1  2/234 (0.85%)  0/235 (0.00%) 
Hiccups * 1  0/234 (0.00%)  1/235 (0.43%) 
Epistaxis * 1  5/234 (2.14%)  4/235 (1.70%) 
Dyspnea * 1  63/234 (26.92%)  51/235 (21.70%) 
Cough * 1  27/234 (11.54%)  38/235 (16.17%) 
Wheezing * 1  2/234 (0.85%)  1/235 (0.43%) 
Atelectasis * 1  0/234 (0.00%)  2/235 (0.85%) 
Allergic Rhinitis * 1  12/234 (5.13%)  5/235 (2.13%) 
Skin and subcutaneous tissue disorders     
Urticaria * 1  2/234 (0.85%)  0/235 (0.00%) 
Skin Ulceration * 1  1/234 (0.43%)  1/235 (0.43%) 
Skin Induration * 1  1/234 (0.43%)  0/235 (0.00%) 
Skin Hyperpigmentation * 1  4/234 (1.71%)  1/235 (0.43%) 
Scalp Pain * 1  3/234 (1.28%)  4/235 (1.70%) 
Rash Acneiform * 1  11/234 (4.70%)  18/235 (7.66%) 
Purpura * 1  1/234 (0.43%)  1/235 (0.43%) 
Pruritus * 1  16/234 (6.84%)  11/235 (4.68%) 
Pain Of Skin * 1  2/234 (0.85%)  1/235 (0.43%) 
Rash Maculo-Papular * 1  27/234 (11.54%)  24/235 (10.21%) 
Nail Ridging * 1  0/234 (0.00%)  1/235 (0.43%) 
Nail Discoloration * 1  3/234 (1.28%)  4/235 (1.70%) 
Telangiectasia * 1  0/234 (0.00%)  1/235 (0.43%) 
Hyperhidrosis * 1  3/234 (1.28%)  1/235 (0.43%) 
Dry Skin * 1  12/234 (5.13%)  11/235 (4.68%) 
Bullous Dermatitis * 1  1/234 (0.43%)  0/235 (0.00%) 
Alopecia * 1  146/234 (62.39%)  131/235 (55.74%) 
Vascular disorders     
Thromboembolic Event * 1  20/234 (8.55%)  28/235 (11.91%) 
Superficial Thrombophlebitis * 1  0/234 (0.00%)  1/235 (0.43%) 
Phlebitis * 1  3/234 (1.28%)  1/235 (0.43%) 
Lymphedema * 1  3/234 (1.28%)  2/235 (0.85%) 
Hypotension * 1  5/234 (2.14%)  8/235 (3.40%) 
Hypertension * 1  40/234 (17.09%)  47/235 (20.00%) 
Hot Flashes * 1  24/234 (10.26%)  28/235 (11.91%) 
Hematoma * 1  2/234 (0.85%)  0/235 (0.00%) 
Flushing * 1  7/234 (2.99%)  3/235 (1.28%) 
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
Layout table for Results Point of Contact information
Name/Title: Christopher Purdy on behalf of Michael Sill, PhD
Organization: NRG Oncology
Phone: (716) 845-1300 ext 2296
EMail: purdyc@nrgoncology.org
Layout table for additonal information
Responsible Party: GOG Foundation ( Gynecologic Oncology Group )
ClinicalTrials.gov Identifier: NCT02065687    
Other Study ID Numbers: GOG-0286B
NCI-2013-02284 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
s14-01068
GOG-0286B
GOG-0286B ( Other Identifier: NRG Oncology )
GOG-0286B ( Other Identifier: CTEP )
U10CA180830 ( U.S. NIH Grant/Contract )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: February 14, 2014
First Posted: February 19, 2014
Results First Submitted: April 24, 2020
Results First Posted: January 12, 2021
Last Update Posted: January 12, 2021