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Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, 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: NCT00954174
Recruitment Status : Active, not recruiting
First Posted : August 7, 2009
Results First Posted : August 10, 2020
Last Update Posted : September 30, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mixed Mesodermal (Mullerian) Tumor
Ovarian Carcinosarcoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Stage I Ovarian Cancer AJCC v6 and v7
Stage IA Fallopian Tube Cancer AJCC v6 and v7
Stage IA Ovarian Cancer AJCC v6 and v7
Stage IA Uterine Sarcoma AJCC v7
Stage IB Fallopian Tube Cancer AJCC v6 and v7
Stage IB Ovarian Cancer AJCC v6 and v7
Stage IB Uterine Sarcoma AJCC v7
Stage IC Fallopian Tube Cancer AJCC v6 and v7
Stage IC Ovarian Cancer AJCC v6 and v7
Stage IC Uterine Sarcoma AJCC v7
Stage II Ovarian Cancer AJCC v6 and v7
Stage IIA Fallopian Tube Cancer AJCC v6 and v7
Stage IIA Ovarian Cancer AJCC V6 and v7
Stage IIA Uterine Sarcoma AJCC v7
Stage IIB Fallopian Tube Cancer AJCC v6 and v7
Stage IIB Ovarian Cancer AJCC v6 and v7
Stage IIB Uterine Sarcoma AJCC v7
Stage IIC Fallopian Tube Cancer AJCC v6 and v7
Stage IIC Ovarian Cancer AJCC v6 and v7
Stage IIIA Fallopian Tube Cancer AJCC v7
Stage IIIA Ovarian Cancer AJCC v6 and v7
Stage IIIA Primary Peritoneal Cancer AJCC v7
Stage IIIA Uterine Sarcoma AJCC v7
Stage IIIB Fallopian Tube Cancer AJCC v7
Stage IIIB Ovarian Cancer AJCC v6 and v7
Stage IIIB Primary Peritoneal Cancer AJCC v7
Stage IIIB Uterine Sarcoma AJCC v7
Stage IIIC Fallopian Tube Cancer AJCC v7
Stage IIIC Ovarian Cancer AJCC v6 and v7
Stage IIIC Primary Peritoneal Cancer AJCC v7
Stage IIIC Uterine Sarcoma AJCC v7
Stage IV Fallopian Tube Cancer AJCC v6 and v7
Stage IV Ovarian Cancer AJCC v6 and v7
Stage IV Primary Peritoneal Cancer AJCC v7
Stage IVA Uterine Sarcoma AJCC v7
Stage IVB Uterine Sarcoma AJCC v7
Uterine Carcinosarcoma
Interventions Drug: Carboplatin
Drug: Ifosfamide
Drug: Paclitaxel
Other: Quality-of-Life Assessment
Enrollment 637
Recruitment Details A total of 637 subjects were enrolled between 08/17/2009 and 3/24/14. Enrollment initially included uterine carcinosarcoma and was expanded to ovarian carcinosarcoma in June 2010 and then to include fallopian tube and peritoneal carcinosarcoma in October 2013. The primary analysis was restricted to patients with uterine carcinosarcoma.
Pre-assignment Details  
Arm/Group Title Regimen I - Uterine Carcinsarcoma Subjects Regimen II - Uterine Carcinsarcoma Subjects Regimen III - Non-uterine Carcinsarcoma Subjects Regimen IV - Non-uterine Carcinsarcoma Subjects
Hide Arm/Group Description Paclitaxel 175 mg/m2 IV over 3 hours Day 1. Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6 Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
Period Title: Overall Study
Started 268 268 51 50
Completed 142 145 27 25
Not Completed 126 123 24 25
Reason Not Completed
Adverse Event             28             23             4             9
Death             4             2             0             0
Lack of Efficacy             32             22             8             6
Withdrawal by Subject             14             10             4             3
Medical Reason             4             2             1             0
Ineligible             40             47             7             4
Never Treated             4             17             0             3
Arm/Group Title Regimen I - Uterine Carcinsarcoma Subjects Regimen II - Uterine Carcinsarcoma Subjects Regimen III - Non-uterine Carcinsarcoma Subjects Regimen IV - Non-uterine Carcinsarcoma Subjects Total
Hide Arm/Group Description Paclitaxel 175 mg/m2 IV over 3 hours Day 1. Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6 Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6 Total of all reporting groups
Overall Number of Baseline Participants 228 221 44 46 539
Hide Baseline Analysis Population Description
Eligible patients
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 228 participants 221 participants 44 participants 46 participants 539 participants
20-29 years
0
   0.0%
3
   1.4%
0
   0.0%
0
   0.0%
3
   0.6%
30-39 years
1
   0.4%
1
   0.5%
2
   4.5%
0
   0.0%
4
   0.7%
40-49 years
12
   5.3%
8
   3.6%
3
   6.8%
2
   4.3%
25
   4.6%
50-59 years
46
  20.2%
45
  20.4%
12
  27.3%
18
  39.1%
121
  22.4%
60-69 years
111
  48.7%
111
  50.2%
15
  34.1%
15
  32.6%
252
  46.8%
70-89 years
58
  25.4%
53
  24.0%
12
  27.3%
11
  23.9%
134
  24.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 228 participants 221 participants 44 participants 46 participants 539 participants
Female
228
 100.0%
221
 100.0%
44
 100.0%
46
 100.0%
539
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 228 participants 221 participants 44 participants 46 participants 539 participants
Hispanic or Latino
4
   1.8%
8
   3.6%
2
   4.5%
3
   6.5%
17
   3.2%
Not Hispanic or Latino
215
  94.3%
206
  93.2%
42
  95.5%
40
  87.0%
503
  93.3%
Unknown or Not Reported
9
   3.9%
7
   3.2%
0
   0.0%
3
   6.5%
19
   3.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 228 participants 221 participants 44 participants 46 participants 539 participants
American Indian or Alaska Native
2
   0.9%
1
   0.5%
0
   0.0%
0
   0.0%
3
   0.6%
Asian
9
   3.9%
9
   4.1%
2
   4.5%
4
   8.7%
24
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
66
  28.9%
72
  32.6%
4
   9.1%
4
   8.7%
146
  27.1%
White
150
  65.8%
133
  60.2%
37
  84.1%
36
  78.3%
356
  66.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.4%
6
   2.7%
1
   2.3%
2
   4.3%
10
   1.9%
1.Primary Outcome
Title Overall Survival
Hide Description Measured in months from randomization to last contact or death. Primary analysis was restricted to the eligible uterine carcinosarcoma cohort.
Time Frame From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 115 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients
Arm/Group Title Regimen I- Uterine Carcinsarcoma Subjects Regimen II - Uterine Carcinsarcoma Subjects
Hide Arm/Group Description:
Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
Overall Number of Participants Analyzed 228 221
Median (95% Confidence Interval)
Unit of Measure: months
37.3
(25.7 to 49.0)
29
(21.9 to 43.1)
2.Secondary Outcome
Title Duration of Progression-free Survival
Hide Description Measured in months from randomization to last contact or the earlier of the date of progression or death.
Time Frame Approximately 9 years and 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients
Arm/Group Title Regimen I - Uterine Carcinsarcoma Subjects Regimen II - Uterine Carcinsarcoma Subjects Regimen III - Non-uterine Carcinsarcoma Subjects Regimen IV - Non-uterine Carcinsarcoma Subjects
Hide Arm/Group Description:
Paclitaxel 175 mg/m2 IV over 3 hours Day 1. Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
Overall Number of Participants Analyzed 228 221 44 46
Median (95% Confidence Interval)
Unit of Measure: months
16.3
(13.0 to 18.9)
11.7
(10.1 to 17.3)
14.6
(8.1 to 16.4)
10.3
(8.5 to 19.0)
3.Secondary Outcome
Title Incidence of Adverse Events as Assessed by CTCAE Version 3.0
Hide Description Maximum grade experienced among all treated and eligible patients. The grades are described by severity. Grade 1 is the lowest (most mild) and Grade 5 being death (most severe). Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
Time Frame Patients were assessed for adverse events during active protocol treatment and up to 30 days after the last cycle of treatment on the protocol.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated and Eligible subjects. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
Arm/Group Title Regimen I - Uterine and Non-Uterine Subjects Regimen II - All Uterine and Non-Uterine Subjects
Hide Arm/Group Description:
Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
Overall Number of Participants Analyzed 268 247
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
3
   1.1%
3
   1.2%
Grade 2
22
   8.2%
80
  32.4%
Grade 3
107
  39.9%
97
  39.3%
Grade 4
130
  48.5%
61
  24.7%
Grade 5
6
   2.2%
3
   1.2%
4.Secondary Outcome
Title Patient-Reported Quality of Life (QOL) - Baseline
Hide Description Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
Time Frame Baseline - Prior to study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who provided baseline assessments.
Arm/Group Title Regimen I - Uterine and Non-Uterine Subjects Regimen II - Uterine and Non-Uterine Subjects
Hide Arm/Group Description:

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1.

Carboplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I.

Ifosfamide: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 205 184
Mean (Standard Error)
Unit of Measure: units on a scale (time point)
96.2  (1.1) 97.5  (1.2)
5.Secondary Outcome
Title Patient Reported Quality of Life (QOL) - Post Baseline
Hide Description Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
Time Frame Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1.
Hide Outcome Measure Data
Hide Analysis Population Description
Provided baseline and ≥ 1 follow-up assessments
Arm/Group Title Regimen I - Uterine and Non-Uterine Subjects Regimen II - Uterine and Non-Uterine Subjects
Hide Arm/Group Description:

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1.

Carboplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I.

Ifosfamide: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 205 184
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale (time point)
Pre-cycle 3 93.3  (0.9) 93.3  (1.0)
Pree-cycle 6 91.6  (1.1) 91.6  (1.1)
30 weeks post cycle 1 98.0  (1.1) 97.6  (1.3)
6.Secondary Outcome
Title Patient Reported Peripheral Neuropathy Symptoms - Baseline
Hide Description Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
Time Frame Baseline (Pre cycle 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who provided baseline assessment
Arm/Group Title Regimen I - Uterine and Non-Uterine Subjects Regimen II - Uterine and Non-Uterine Subjects
Hide Arm/Group Description:

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1.

Carboplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I.

Ifosfamide: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 205 184
Mean (Standard Error)
Unit of Measure: units on a scale-baseline
40.2  (0.3) 41.0  (0.3)
7.Secondary Outcome
Title Patient-reported Peripheral Neuropathy Symptoms - Post Baseline
Hide Description Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms.Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
Time Frame Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Provided baseline and ≥ 1 follow-up assessments
Arm/Group Title Regimen I - Uterine and Non-Uterine Subjects Regimen II - Uterine and Non-Uterine Subjects
Hide Arm/Group Description:

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1.

Carboplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I.

Ifosfamide: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 205 184
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Prior to cycle 3 37.2  (0.4) 37.0  (0.5)
Prior to cycle 6 34.1  (0.6) 34.2  (0.6)
30 weeks post cycle 1 34.8  (0.6) 34.9  (0.6)
Time Frame Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.
Adverse Event Reporting Description Eligible and treated participants were affected if they experienced grade 1-5 adverse event. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
 
Arm/Group Title Regimen I - Uterine and Non-uterine Carcinosarcoma Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects
Hide Arm/Group Description Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
All-Cause Mortality
Regimen I - Uterine and Non-uterine Carcinosarcoma Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   160/272 (58.82%)      160/267 (59.93%)    
Hide Serious Adverse Events
Regimen I - Uterine and Non-uterine Carcinosarcoma Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/268 (29.85%)      68/247 (27.53%)    
Blood and lymphatic system disorders     
Neutrophils * 1  32/268 (11.94%)  12/247 (4.86%) 
Platelets * 1  2/268 (0.75%)  1/247 (0.40%) 
Blood/Bone Marrow - Other * 1  1/268 (0.37%)  1/247 (0.40%) 
Cd4 Count * 1  0/268 (0.00%)  1/247 (0.40%) 
Leukocytes * 1  1/268 (0.37%)  1/247 (0.40%) 
Hemoglobin * 1  1/268 (0.37%)  2/247 (0.81%) 
Cardiac disorders     
S/N Arrhythmia: Atrial Fibrillation * 1  1/268 (0.37%)  1/247 (0.40%) 
Vasovagal Episode * 1  1/268 (0.37%)  0/247 (0.00%) 
Ventricular Arrhythmia - Fibrillation * 1  1/268 (0.37%)  0/247 (0.00%) 
Cardiac Ischemia/Infarction * 1  1/268 (0.37%)  1/247 (0.40%) 
Hypertension * 1  1/268 (0.37%)  0/247 (0.00%) 
Left Venticular Diastolic Dysfunction * 1  1/268 (0.37%)  0/247 (0.00%) 
Lt Ventricular Systolic Dysfunction * 1  0/268 (0.00%)  1/247 (0.40%) 
Hypotension * 1  0/268 (0.00%)  1/247 (0.40%) 
Cardipulmonary Arrest * 1  0/268 (0.00%)  1/247 (0.40%) 
Gastrointestinal disorders     
Ulcer,gi - Esophagus * 1  0/268 (0.00%)  1/247 (0.40%) 
Perforation, Gi - Colon * 1  1/268 (0.37%)  0/247 (0.00%) 
Esophagitis * 1  1/268 (0.37%)  0/247 (0.00%) 
Obstruction, Gi - Small Bowel Nos * 1  0/268 (0.00%)  2/247 (0.81%) 
Vomiting * 1  0/268 (0.00%)  2/247 (0.81%) 
Dehydration * 1  6/268 (2.24%)  3/247 (1.21%) 
Constipation * 1  1/268 (0.37%)  0/247 (0.00%) 
Nausea * 1  3/268 (1.12%)  0/247 (0.00%) 
Diarrhea * 1  0/268 (0.00%)  1/247 (0.40%) 
General disorders     
Fatigue * 1  2/268 (0.75%)  0/247 (0.00%) 
Death No Ctcae Term - Disease Progression Nos * 1  1/268 (0.37%)  1/247 (0.40%) 
Death No Ctcae Term - Death Nos * 1  2/268 (0.75%)  0/247 (0.00%) 
Death No Ctcae Term - Multi-Organ Failure * 1  1/268 (0.37%)  0/247 (0.00%) 
Pain - Other * 1  1/268 (0.37%)  1/247 (0.40%) 
Pain: Pelvis * 1  0/268 (0.00%)  1/247 (0.40%) 
Pain: Chest /Thorax Nos * 1  0/268 (0.00%)  3/247 (1.21%) 
Pain: Head/Headache * 1  1/268 (0.37%)  0/247 (0.00%) 
Pain: Extremity-Limb * 1  1/268 (0.37%)  0/247 (0.00%) 
Pain: Back * 1  0/268 (0.00%)  1/247 (0.40%) 
Pain: Abdominal Pain Nos * 1  3/268 (1.12%)  0/247 (0.00%) 
Pain: Cardiac/ Heart * 1  0/268 (0.00%)  1/247 (0.40%) 
Cytokine Release Syndrome * 1  2/268 (0.75%)  0/247 (0.00%) 
Death No Ctcae Term - Sudden Death * 1  0/268 (0.00%)  0 1/247 (0.40%)  1
Infections and infestations     
Inf W/Gr 3 Or 4 Anc: Wound * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf W/Gr 3 Or 4 Anc: Blood * 1  1/268 (0.37%)  0/247 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) * 1  1/268 (0.37%)  0/247 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Blood * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) * 1  1/268 (0.37%)  1/247 (0.40%) 
Febrile Neutropenia * 1  3/268 (1.12%)  2/247 (0.81%) 
Inf Unknown Anc: Lung (Pneumonia) * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf Unknown Anc: Blood * 1  1/268 (0.37%)  0/247 (0.00%) 
Infection - Other * 1  1/268 (0.37%)  2/247 (0.81%) 
Inf W/Gr 3 Or 4 Anc: Abdomen Nos * 1  1/268 (0.37%)  0/247 (0.00%) 
Inf Unknown Anc: Pelvis Nos * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf Unknown Anc: Urinary Tract Nos * 1  1/268 (0.37%)  1/247 (0.40%) 
Inf Unknown Anc: Foreign Body * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf Unknown Anc: Catheter-Related * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf Unknown Anc: Colon * 1  1/268 (0.37%)  0/247 (0.00%) 
Inf Unknown Anc: Abdomen Nos * 1  1/268 (0.37%)  0/247 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Vulva * 1  0/268 (0.00%)  1/247 (0.40%) 
Metabolism and nutrition disorders     
Creatinine * 1  2/268 (0.75%)  1/247 (0.40%) 
Hypophosphatemia * 1  0/268 (0.00%)  1/247 (0.40%) 
Hyperglycemia * 1  2/268 (0.75%)  1/247 (0.40%) 
Hypokalemia * 1  0/268 (0.00%)  2/247 (0.81%) 
Hypoglycemia * 1  1/268 (0.37%)  0/247 (0.00%) 
Nervous system disorders     
Syncope * 1  2/268 (0.75%)  1/247 (0.40%) 
Apnea * 1  1/268 (0.37%)  0/247 (0.00%) 
Encephalopathy * 1  0/268 (0.00%)  2/247 (0.81%) 
Speech Impairment * 1  0/268 (0.00%)  1/247 (0.40%) 
Cognitive Disturbance * 1  1/268 (0.37%)  0/247 (0.00%) 
Confusion * 1  0/268 (0.00%)  5/247 (2.02%) 
Dizziness * 1  0/268 (0.00%)  1/247 (0.40%) 
Renal and urinary disorders     
Renal/Genitourinary - Other * 1  1/268 (0.37%)  1/247 (0.40%) 
Fistula, Gu - Vagina * 1  0/268 (0.00%)  1/247 (0.40%) 
Renal Failure * 1  1/268 (0.37%)  3/247 (1.21%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax * 1  0/268 (0.00%)  1/247 (0.40%) 
Hypoxia * 1  0/268 (0.00%)  1/247 (0.40%) 
Pleural Effusion * 1  2/268 (0.75%)  0/247 (0.00%) 
Dyspnea * 1  1/268 (0.37%)  1/247 (0.40%) 
Skin and subcutaneous tissue disorders     
Injection Site Reaction * 1  0/268 (0.00%)  1/247 (0.40%) 
Vascular disorders     
Hemorrhage, Gu - Vagina * 1  1/268 (0.37%)  0/247 (0.00%) 
Thrombosis/Embolism (Vascular Access-Related) * 1  2/268 (0.75%)  0/247 (0.00%) 
Thrombosis/Thrombus/Embolism * 1  2/268 (0.75%)  4/247 (1.62%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Regimen I - Uterine and Non-uterine Carcinosarcoma Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   268/268 (100.00%)      244/247 (98.79%)    
Blood and lymphatic system disorders     
Neutrophils * 1  245/268 (91.42%)  116/247 (46.96%) 
Platelets * 1  178/268 (66.42%)  137/247 (55.47%) 
Blood/Bone Marrow - Other * 1  7/268 (2.61%)  9/247 (3.64%) 
Bone Marrow Cellularity * 1  1/268 (0.37%)  0/247 (0.00%) 
Leukocytes * 1  239/268 (89.18%)  164/247 (66.40%) 
Lymphopenia * 1  18/268 (6.72%)  26/247 (10.53%) 
Hemoglobin * 1  249/268 (92.91%)  232/247 (93.93%) 
Edema: Trunk/Genital * 1  1/268 (0.37%)  1/247 (0.40%) 
Edema: Limb * 1  43/268 (16.04%)  40/247 (16.19%) 
Edema: Head And Neck * 1  1/268 (0.37%)  2/247 (0.81%) 
Cardiac disorders     
S/N Arrhythmia: Atrial Fibrillation * 1  3/268 (1.12%)  1/247 (0.40%) 
Conduction Abnml: Conduction Abnormality Nos * 1  0/268 (0.00%)  1/247 (0.40%) 
Palpitations * 1  8/268 (2.99%)  8/247 (3.24%) 
Cardiac Arrhythmia - Other * 1  1/268 (0.37%)  1/247 (0.40%) 
Ventricular Arrhythmia - Tachycardia * 1  1/268 (0.37%)  1/247 (0.40%) 
S/N Arrhythmia: Sinus Tachycardia * 1  4/268 (1.49%)  6/247 (2.43%) 
Supraventricular Tachycardia * 1  0/268 (0.00%)  1/247 (0.40%) 
S/N Arrhythmia: Sinus Bradycardia * 1  0/268 (0.00%)  1/247 (0.40%) 
Cardiac Ischemia/Infarction * 1  0/268 (0.00%)  2/247 (0.81%) 
Hypertension * 1  26/268 (9.70%)  25/247 (10.12%) 
Left Venticular Diastolic Dysfunction * 1  1/268 (0.37%)  0/247 (0.00%) 
Lt Ventricular Systolic Dysfunction * 1  0/268 (0.00%)  2/247 (0.81%) 
Cardiac General - Other * 1  1/268 (0.37%)  1/247 (0.40%) 
Cardiac Troponin I (Ctni) * 1  0/268 (0.00%)  1/247 (0.40%) 
Cardiac Troponin T (Ctnt) * 1  1/268 (0.37%)  0/247 (0.00%) 
Hypotension * 1  12/268 (4.48%)  8/247 (3.24%) 
Ear and labyrinth disorders     
Auditory/Ear - Other * 1  1/268 (0.37%)  2/247 (0.81%) 
Hearing (Without Monitoring Program) * 1  4/268 (1.49%)  0/247 (0.00%) 
Tinnitus * 1  8/268 (2.99%)  4/247 (1.62%) 
Hearing (Monitoring Program) * 1  2/268 (0.75%)  0/247 (0.00%) 
Endocrine disorders     
Hot Flashes * 1  17/268 (6.34%)  19/247 (7.69%) 
Diabetes * 1  1/268 (0.37%)  3/247 (1.21%) 
Hypothyroidism * 1  1/268 (0.37%)  0/247 (0.00%) 
Eye disorders     
Ocular/Visual - Other * 1  1/268 (0.37%)  2/247 (0.81%) 
Watery Eye * 1  2/268 (0.75%)  5/247 (2.02%) 
Dry Eye * 1  3/268 (1.12%)  4/247 (1.62%) 
Cataract * 1  2/268 (0.75%)  2/247 (0.81%) 
Photophobia * 1  1/268 (0.37%)  0/247 (0.00%) 
Flashing Lights/Floaters * 1  3/268 (1.12%)  4/247 (1.62%) 
Blurred Vision * 1  18/268 (6.72%)  13/247 (5.26%) 
Keratitis * 1  1/268 (0.37%)  0/247 (0.00%) 
Eyelid Dysfunction * 1  0/268 (0.00%)  1/247 (0.40%) 
Gastrointestinal disorders     
Enteritis * 1  1/268 (0.37%)  0/247 (0.00%) 
Flatulence * 1  2/268 (0.75%)  1/247 (0.40%) 
Ulcer,gi - Duodenum * 1  1/268 (0.37%)  0/247 (0.00%) 
Obstruction, Gi - Colon * 1  0/268 (0.00%)  2/247 (0.81%) 
Gastritis * 1  1/268 (0.37%)  3/247 (1.21%) 
Esophagitis * 1  1/268 (0.37%)  0/247 (0.00%) 
Hemorrhoids * 1  5/268 (1.87%)  3/247 (1.21%) 
Heartburn * 1  21/268 (7.84%)  20/247 (8.10%) 
Dental: Teeth * 1  1/268 (0.37%)  0/247 (0.00%) 
Ascites * 1  1/268 (0.37%)  4/247 (1.62%) 
Dysphagia * 1  4/268 (1.49%)  2/247 (0.81%) 
Distention * 1  7/268 (2.61%)  8/247 (3.24%) 
Taste Alteration * 1  25/268 (9.33%)  42/247 (17.00%) 
Incontinence, Anal * 1  1/268 (0.37%)  1/247 (0.40%) 
Dry Mouth * 1  4/268 (1.49%)  5/247 (2.02%) 
Mucositis (Functional/Sympt) - Oral Cavity * 1  5/268 (1.87%)  14/247 (5.67%) 
Obstruction, Gi - Small Bowel Nos * 1  1/268 (0.37%)  2/247 (0.81%) 
Mucositis (Clinical Exam) - Oral Cavity * 1  10/268 (3.73%)  12/247 (4.86%) 
Mucositis (Clinical Exam) - Larynx * 1  0/268 (0.00%)  1/247 (0.40%) 
Vomiting * 1  51/268 (19.03%)  64/247 (25.91%) 
Anorexia * 1  61/268 (22.76%)  67/247 (27.13%) 
Dehydration * 1  18/268 (6.72%)  18/247 (7.29%) 
Constipation * 1  129/268 (48.13%)  119/247 (48.18%) 
Nausea * 1  132/268 (49.25%)  131/247 (53.04%) 
Gastrointestinal - Other * 1  3/268 (1.12%)  2/247 (0.81%) 
Diarrhea * 1  77/268 (28.73%)  55/247 (22.27%) 
General disorders     
Constitutional Symptoms - Other * 1  2/268 (0.75%)  4/247 (1.62%) 
Sweating * 1  5/268 (1.87%)  8/247 (3.24%) 
Weight Gain * 1  7/268 (2.61%)  14/247 (5.67%) 
Patient Odor * 1  0/268 (0.00%)  1/247 (0.40%) 
Fever * 1  7/268 (2.61%)  16/247 (6.48%) 
Weight Loss * 1  14/268 (5.22%)  19/247 (7.69%) 
Rigors/Chills * 1  8/268 (2.99%)  7/247 (2.83%) 
Fatigue * 1  192/268 (71.64%)  177/247 (71.66%) 
Insomnia * 1  43/268 (16.04%)  35/247 (14.17%) 
Pain - Other * 1  9/268 (3.36%)  9/247 (3.64%) 
Pain: Urethra * 1  4/268 (1.49%)  4/247 (1.62%) 
Pain: Perineum * 1  1/268 (0.37%)  0/247 (0.00%) 
Pain: Pelvis * 1  4/268 (1.49%)  2/247 (0.81%) 
Pain: Breast * 1  1/268 (0.37%)  1/247 (0.40%) 
Pain: Vagina * 1  1/268 (0.37%)  1/247 (0.40%) 
Pain: Chest /Thorax Nos * 1  7/268 (2.61%)  10/247 (4.05%) 
Pain: Chest Wall * 1  1/268 (0.37%)  4/247 (1.62%) 
Pain: Throat/Pharynx/Larynx * 1  3/268 (1.12%)  5/247 (2.02%) 
Pain: Eye * 1  0/268 (0.00%)  1/247 (0.40%) 
Pain: Head/Headache * 1  30/268 (11.19%)  34/247 (13.77%) 
Pain: Neck * 1  2/268 (0.75%)  2/247 (0.81%) 
Pain: Intestine * 1  1/268 (0.37%)  0/247 (0.00%) 
Pain: Extremity-Limb * 1  32/268 (11.94%)  23/247 (9.31%) 
Pain: Buttock * 1  0/268 (0.00%)  1/247 (0.40%) 
Pain: Back * 1  25/268 (9.33%)  35/247 (14.17%) 
Pain: Joint * 1  58/268 (21.64%)  41/247 (16.60%) 
Pain: Bone * 1  20/268 (7.46%)  45/247 (18.22%) 
Pain: Bladder * 1  2/268 (0.75%)  2/247 (0.81%) 
Pain: Pain Nos * 1  8/268 (2.99%)  1/247 (0.40%) 
Pain: Stomach * 1  4/268 (1.49%)  2/247 (0.81%) 
Pain: Oral Cavity * 1  1/268 (0.37%)  1/247 (0.40%) 
Pain: Esophagus * 1  1/268 (0.37%)  0/247 (0.00%) 
Pain: Dental/Teeth/Peridontal * 1  3/268 (1.12%)  0/247 (0.00%) 
Pain: Abdominal Pain Nos * 1  47/268 (17.54%)  56/247 (22.67%) 
Pain: Scalp * 1  1/268 (0.37%)  1/247 (0.40%) 
Pain: Oral - Gums * 1  0/268 (0.00%)  1/247 (0.40%) 
Pain: Lip * 1  1/268 (0.37%)  0/247 (0.00%) 
Pain: Middle Ear * 1  0/268 (0.00%)  1/247 (0.40%) 
Pain: External Ear * 1  4/268 (1.49%)  0/247 (0.00%) 
Pain: Cardiac/ Heart * 1  1/268 (0.37%)  2/247 (0.81%) 
Pain: Face * 1  2/268 (0.75%)  0/247 (0.00%) 
Pain: Muscle * 1  46/268 (17.16%)  41/247 (16.60%) 
Pain: Anus * 1  1/268 (0.37%)  2/247 (0.81%) 
Pain: Neuralgia * 1  0/268 (0.00%)  1/247 (0.40%) 
Pain: Sinus * 1  0/268 (0.00%)  1/247 (0.40%) 
Syndromes - Other * 1  1/268 (0.37%)  1/247 (0.40%) 
Cytokine Release Syndrome * 1  1/268 (0.37%)  0/247 (0.00%) 
Flu-Like Syndrome * 1  3/268 (1.12%)  1/247 (0.40%) 
Hepatobiliary disorders     
Cholecystitis * 1  1/268 (0.37%)  0/247 (0.00%) 
Immune system disorders     
Allergic Reaction/Hypersensitivity * 1  19/268 (7.09%)  11/247 (4.45%) 
Rhinitis * 1  6/268 (2.24%)  12/247 (4.86%) 
Infections and infestations     
Inf W/Gr 3 Or 4 Anc: Wound * 1  1/268 (0.37%)  0/247 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Blood * 1  1/268 (0.37%)  0/247 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Dental-Tooth * 1  1/268 (0.37%)  0/247 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos * 1  5/268 (1.87%)  4/247 (1.62%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pleura * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) * 1  0/268 (0.00%)  2/247 (0.81%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lymphatic * 1  1/268 (0.37%)  0/247 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Blood * 1  1/268 (0.37%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Wound * 1  5/268 (1.87%)  0/247 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) * 1  2/268 (0.75%)  2/247 (0.81%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related * 1  1/268 (0.37%)  0/247 (0.00%) 
Febrile Neutropenia * 1  5/268 (1.87%)  1/247 (0.40%) 
Inf Unknown Anc: Bone (Osteomyelitis) * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf Unknown Anc: Sinus * 1  1/268 (0.37%)  2/247 (0.81%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth * 1  1/268 (0.37%)  0/247 (0.00%) 
Viral Hepatitis * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  15/268 (5.60%)  17/247 (6.88%) 
Inf Unknown Anc: Blood * 1  0/268 (0.00%)  1/247 (0.40%) 
Infection - Other * 1  5/268 (1.87%)  4/247 (1.62%) 
Inf W/Gr 3 Or 4 Anc: Bladder (Urinary) * 1  1/268 (0.37%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral * 1  0/268 (0.00%)  2/247 (0.81%) 
Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums * 1  1/268 (0.37%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Conjunctiva * 1  1/268 (0.37%)  0/247 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus * 1  0/268 (0.00%)  2/247 (0.81%) 
Inf Unknown Anc: Upper Airway Nos * 1  2/268 (0.75%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina * 1  1/268 (0.37%)  2/247 (0.81%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus * 1  1/268 (0.37%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos * 1  1/268 (0.37%)  1/247 (0.40%) 
Inf Unknown Anc: Bronchus * 1  0/268 (0.00%)  2/247 (0.81%) 
Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf Unknown Anc: Urinary Tract Nos * 1  5/268 (1.87%)  6/247 (2.43%) 
Inf Unknown Anc: Bladder (Urinary) * 1  1/268 (0.37%)  2/247 (0.81%) 
Inf Unknown Anc: Wound * 1  2/268 (0.75%)  1/247 (0.40%) 
Inf Unknown Anc: Foreign Body * 1  1/268 (0.37%)  0/247 (0.00%) 
Inf Unknown Anc: Catheter-Related * 1  1/268 (0.37%)  1/247 (0.40%) 
Inf W/Gr 3 Or 4 Anc: Vagina * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf W/Gr 3 Or 4 Anc: Pelvis Nos * 1  1/268 (0.37%)  1/247 (0.40%) 
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia) * 1  1/268 (0.37%)  2/247 (0.81%) 
Inf W/Gr 3 Or 4 Anc: Bronchus * 1  0/268 (0.00%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney * 1  1/268 (0.37%)  1/247 (0.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder * 1  2/268 (0.75%)  3/247 (1.21%) 
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos * 1  3/268 (1.12%)  2/247 (0.81%) 
Metabolism and nutrition disorders     
Ast * 1  20/268 (7.46%)  19/247 (7.69%) 
Gfr * 1  5/268 (1.87%)  1/247 (0.40%) 
Metabolic/Laboratory - Other * 1  8/268 (2.99%)  4/247 (1.62%) 
Proteinuria * 1  1/268 (0.37%)  13/247 (5.26%) 
Creatinine * 1  30/268 (11.19%)  34/247 (13.77%) 
Hypoalbuminemia * 1  41/268 (15.30%)  46/247 (18.62%) 
Ggt * 1  0/268 (0.00%)  2/247 (0.81%) 
Alt * 1  14/268 (5.22%)  21/247 (8.50%) 
Alkaline Phosphatase * 1  23/268 (8.58%)  50/247 (20.24%) 
Bilirubin * 1  5/268 (1.87%)  3/247 (1.21%) 
Lipase * 1  1/268 (0.37%)  0/247 (0.00%) 
Hypermagnesemia * 1  2/268 (0.75%)  5/247 (2.02%) 
Hypophosphatemia * 1  13/268 (4.85%)  24/247 (9.72%) 
Hyponatremia * 1  38/268 (14.18%)  25/247 (10.12%) 
Hypertriglyceridemia * 1  1/268 (0.37%)  1/247 (0.40%) 
Bicarbonate, Serum-Low * 1  0/268 (0.00%)  2/247 (0.81%) 
Acidosis * 1  1/268 (0.37%)  0/247 (0.00%) 
Hypernatremia * 1  3/268 (1.12%)  8/247 (3.24%) 
Hypocalcemia * 1  22/268 (8.21%)  36/247 (14.57%) 
Hyperkalemia * 1  9/268 (3.36%)  6/247 (2.43%) 
Hyperglycemia * 1  62/268 (23.13%)  64/247 (25.91%) 
Hypokalemia * 1  48/268 (17.91%)  49/247 (19.84%) 
Hypoglycemia * 1  5/268 (1.87%)  8/247 (3.24%) 
Hypercalcemia * 1  14/268 (5.22%)  12/247 (4.86%) 
Hypomagnesemia * 1  69/268 (25.75%)  18/247 (7.29%) 
Musculoskeletal and connective tissue disorders     
Myositis * 1  1/268 (0.37%)  0/247 (0.00%) 
Musculoskeletal/St: Other * 1  4/268 (1.49%)  4/247 (1.62%) 
Osteoporosis * 1  0/268 (0.00%)  1/247 (0.40%) 
Joint-Function * 1  1/268 (0.37%)  0/247 (0.00%) 
Fracture * 1  1/268 (0.37%)  1/247 (0.40%) 
Gait/Walking * 1  2/268 (0.75%)  3/247 (1.21%) 
Arthritis * 1  6/268 (2.24%)  5/247 (2.02%) 
Muscle Weakness - Whole Body/Generalized * 1  24/268 (8.96%)  15/247 (6.07%) 
Muscle Weakness - Trunk * 1  0/268 (0.00%)  1/247 (0.40%) 
Muscle Weakness - Extremity-Upper * 1  0/268 (0.00%)  1/247 (0.40%) 
Muscle Weakness - Extremity-Lower * 1  4/268 (1.49%)  5/247 (2.02%) 
Nervous system disorders     
Syncope * 1  4/268 (1.49%)  5/247 (2.02%) 
Involuntary Movement * 1  3/268 (1.12%)  4/247 (1.62%) 
Pyramidal Tract Dysfunction * 1  0/268 (0.00%)  1/247 (0.40%) 
Psychosis * 1  1/268 (0.37%)  1/247 (0.40%) 
Myelitis * 1  0/268 (0.00%)  2/247 (0.81%) 
Neurology - Other * 1  2/268 (0.75%)  2/247 (0.81%) 
Mental Status * 1  0/268 (0.00%)  1/247 (0.40%) 
Mood Alteration - Depression * 1  22/268 (8.21%)  31/247 (12.55%) 
Mood Alteration - Anxiety * 1  27/268 (10.07%)  27/247 (10.93%) 
Mood Alteration - Agitation * 1  4/268 (1.49%)  2/247 (0.81%) 
Tremor * 1  1/268 (0.37%)  3/247 (1.21%) 
Speech Impairment * 1  2/268 (0.75%)  1/247 (0.40%) 
Seizure * 1  2/268 (0.75%)  2/247 (0.81%) 
Personality * 1  1/268 (0.37%)  0/247 (0.00%) 
Somnolence * 1  1/268 (0.37%)  4/247 (1.62%) 
Cognitive Disturbance * 1  4/268 (1.49%)  2/247 (0.81%) 
Cns Ischemia * 1  0/268 (0.00%)  1/247 (0.40%) 
Ataxia * 1  0/268 (0.00%)  1/247 (0.40%) 
Confusion * 1  4/268 (1.49%)  11/247 (4.45%) 
Memory Impairment * 1  11/268 (4.10%)  10/247 (4.05%) 
Dizziness * 1  33/268 (12.31%)  27/247 (10.93%) 
Neuropathy,cranial - Cn Vii Motor-Face * 1  1/268 (0.37%)  0/247 (0.00%) 
Neuropathy-Sensory * 1  178/268 (66.42%)  158/247 (63.97%) 
Neuropathy-Motor * 1  5/268 (1.87%)  6/247 (2.43%) 
Renal and urinary disorders     
Renal/Genitourinary - Other * 1  2/268 (0.75%)  13/247 (5.26%) 
Stricture, Anastomotic, Gu - Ureter * 1  1/268 (0.37%)  0/247 (0.00%) 
Leak, Gu - Vagina * 1  0/268 (0.00%)  1/247 (0.40%) 
Leak, Gu - Bladder * 1  1/268 (0.37%)  1/247 (0.40%) 
Cystitis * 1  3/268 (1.12%)  4/247 (1.62%) 
Urinary Color Change * 1  1/268 (0.37%)  0/247 (0.00%) 
Urinary Retention * 1  2/268 (0.75%)  2/247 (0.81%) 
Urinary Electrolyte Wasting * 1  0/268 (0.00%)  1/247 (0.40%) 
Obstruction, Gu - Ureter * 1  1/268 (0.37%)  2/247 (0.81%) 
Incontinence, Urinary * 1  15/268 (5.60%)  11/247 (4.45%) 
Fistula, Gu - Vagina * 1  0/268 (0.00%)  1/247 (0.40%) 
Bladder Spasm * 1  0/268 (0.00%)  2/247 (0.81%) 
Renal Failure * 1  7/268 (2.61%)  9/247 (3.64%) 
Urinary Frequency * 1  25/268 (9.33%)  16/247 (6.48%) 
Reproductive system and breast disorders     
Nipple/Areolar * 1  0/268 (0.00%)  1/247 (0.40%) 
Vaginal Dryness * 1  3/268 (1.12%)  2/247 (0.81%) 
Sexual/Reproductive Function: Other * 1  0/268 (0.00%)  1/247 (0.40%) 
Vaginitis * 1  3/268 (1.12%)  0/247 (0.00%) 
Vaginal Mucositis * 1  0/268 (0.00%)  1/247 (0.40%) 
Vaginal Discharge * 1  4/268 (1.49%)  10/247 (4.05%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary: Other * 1  5/268 (1.87%)  2/247 (0.81%) 
Prolonged Intubation * 1  1/268 (0.37%)  0/247 (0.00%) 
Nasal/Paranasal Reactions * 1  6/268 (2.24%)  4/247 (1.62%) 
Bronchospasm * 1  0/268 (0.00%)  1/247 (0.40%) 
Aspiration * 1  0/268 (0.00%)  1/247 (0.40%) 
Voice Changes * 1  2/268 (0.75%)  5/247 (2.02%) 
Pulmonary Fibrosis * 1  0/268 (0.00%)  1/247 (0.40%) 
Hypoxia * 1  2/268 (0.75%)  2/247 (0.81%) 
Cough * 1  38/268 (14.18%)  37/247 (14.98%) 
Pneumonitis * 1  0/268 (0.00%)  1/247 (0.40%) 
Pleural Effusion * 1  1/268 (0.37%)  4/247 (1.62%) 
Dyspnea * 1  55/268 (20.52%)  48/247 (19.43%) 
Skin and subcutaneous tissue disorders     
Nail Changes * 1  12/268 (4.48%)  15/247 (6.07%) 
Injection Site Reaction * 1  1/268 (0.37%)  2/247 (0.81%) 
Hair Loss/Alopecia (Scalp Or Body) * 1  190/268 (70.90%)  171/247 (69.23%) 
Induration * 1  0/268 (0.00%)  1/247 (0.40%) 
Wound Complication, Non-Infectious * 1  8/268 (2.99%)  6/247 (2.43%) 
Bruising * 1  4/268 (1.49%)  3/247 (1.21%) 
Acne * 1  0/268 (0.00%)  1/247 (0.40%) 
Rash * 1  24/268 (8.96%)  23/247 (9.31%) 
Dry Skin * 1  6/268 (2.24%)  8/247 (3.24%) 
Decubitus * 1  1/268 (0.37%)  0/247 (0.00%) 
Pruritus * 1  10/268 (3.73%)  6/247 (2.43%) 
Urticaria * 1  1/268 (0.37%)  2/247 (0.81%) 
Flushing * 1  1/268 (0.37%)  5/247 (2.02%) 
Hand-Foot * 1  0/268 (0.00%)  1/247 (0.40%) 
Dermatology/Skin - Other * 1  2/268 (0.75%)  3/247 (1.21%) 
Hyperpigmentation * 1  1/268 (0.37%)  13/247 (5.26%) 
Ulceration * 1  1/268 (0.37%)  2/247 (0.81%) 
Vascular disorders     
Inr * 1  3/268 (1.12%)  4/247 (1.62%) 
Coagulopathy - Other * 1  1/268 (0.37%)  0/247 (0.00%) 
Ptt * 1  1/268 (0.37%)  2/247 (0.81%) 
Hemorrhage, Gu - Urinary Nos * 1  1/268 (0.37%)  14/247 (5.67%) 
Hemorrhage, Gu - Vagina * 1  7/268 (2.61%)  4/247 (1.62%) 
Hemorrhage, Gu - Urethra * 1  1/268 (0.37%)  0/247 (0.00%) 
Hemorrhage, Gi - Rectum * 1  2/268 (0.75%)  3/247 (1.21%) 
Hemorrhage, Gi - Peritoneal Cavity * 1  0/268 (0.00%)  1/247 (0.40%) 
Hemorrhage, Gi - Upper Gi Nos * 1  0/268 (0.00%)  1/247 (0.40%) 
Hemorrhage/Pulmonary - Nose * 1  6/268 (2.24%)  7/247 (2.83%) 
Hematoma * 1  0/268 (0.00%)  1/247 (0.40%) 
Hemorrhage, Gu - Uterus * 1  0/268 (0.00%)  1/247 (0.40%) 
Hemorrhage, Gi - Oral Cavity * 1  1/268 (0.37%)  1/247 (0.40%) 
Hemorrhage, Gu - Bladder * 1  1/268 (0.37%)  8/247 (3.24%) 
Hemorrhage/Bleeding - Other * 1  0/268 (0.00%)  2/247 (0.81%) 
Vascular - Other * 1  1/268 (0.37%)  2/247 (0.81%) 
Vein Injury - Jugular * 1  0/268 (0.00%)  1/247 (0.40%) 
Thrombosis/Embolism (Vascular Access-Related) * 1  2/268 (0.75%)  3/247 (1.21%) 
Thrombosis/Thrombus/Embolism * 1  15/268 (5.60%)  6/247 (2.43%) 
Phlebitis * 1  1/268 (0.37%)  0/247 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
*
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: Linda Gedeon on behalf of Virginia Filiaci, PhD.
Organization: NRG Oncology
Phone: 716-845-1169
EMail: Linda.Gedeon@roswellpark.org
Layout table for additonal information
Responsible Party: GOG Foundation
ClinicalTrials.gov Identifier: NCT00954174    
Other Study ID Numbers: GOG-0261
NCI-2011-01959 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000651458
GOG-0261 ( Other Identifier: NRG Oncology )
GOG-0261 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: August 6, 2009
First Posted: August 7, 2009
Results First Submitted: March 13, 2020
Results First Posted: August 10, 2020
Last Update Posted: September 30, 2021