Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer

• 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: GOG Foundation
• 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

Participant Flow

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
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

Baseline Characteristics

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
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
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%

Outcome Measures

1. Primary Outcome

Title	Overall Survival
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.

Outcome Measure Data

Analysis Population Description

All eligible patients

Arm/Group Title	Regimen I- Uterine Carcinsarcoma Subjects	Regimen II - Uterine Carcinsarcoma Subjects
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
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

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

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
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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 Virginia Filiaci, PhD.
• Organization: NRG Oncology
• Phone: 716-845-1169
• EMail: Linda.Gedeon@roswellpark.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Powell MA, Filiaci VL, Hensley ML, Huang HQ, Moore KN, Tewari KS, Copeland LJ, Secord AA, Mutch DG, Santin A, Warshal DP, Spirtos NM, DiSilvestro PA, Ioffe OB, Miller DS. Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial. J Clin Oncol. 2022 Mar 20;40(9):968-977. doi: 10.1200/JCO.21.02050. Epub 2022 Jan 10.

• 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