Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 415
Summary
- Conditions
- Ovarian Carcinosarcoma
- Mixed Mesodermal (Mullerian) Tumor
- Stage IIIB Ovarian Cancer AJCC v6 and v7
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Stage IIIC Fallopian Tube Cancer AJCC v7
- Stage IC Fallopian Tube Cancer AJCC v6 and v7
- Stage IIIA Fallopian Tube Cancer AJCC v7
- Stage IIIB Primary Peritoneal Cancer AJCC v7
- Recurrent Primary Peritoneal Carcinoma
- Stage IIIC Primary Peritoneal Cancer AJCC v7
- Stage I Ovarian Cancer AJCC v6 and v7
- Stage IA Fallopian Tube Cancer AJCC v6 and v7
- Stage IB Uterine Sarcoma AJCC v7
- Stage IIIA Primary Peritoneal Cancer AJCC v7
- Stage IIIA Uterine Sarcoma AJCC v7
- Stage IC Uterine Sarcoma AJCC v7
- Stage II Ovarian Cancer AJCC v6 and v7
- Stage IV Fallopian Tube Cancer AJCC v6 and v7
- Uterine Carcinosarcoma
- Stage IA Ovarian Cancer AJCC v6 and v7
- Stage IIB Uterine Sarcoma AJCC v7
- Stage IV Primary Peritoneal Cancer AJCC v7
- Stage IIIC Uterine Sarcoma AJCC v7
- Stage IV Ovarian Cancer AJCC v6 and v7
- Stage IIIC Ovarian Cancer AJCC v6 and v7
- Stage IC Ovarian Cancer AJCC v6 and v7
- Stage IIA Ovarian Cancer AJCC V6 and v7
- Stage IA Uterine Sarcoma AJCC v7
- Stage IB Fallopian Tube Cancer AJCC v6 and v7
- Stage IIIA Ovarian Cancer AJCC v6 and v7
- Stage IIIB Fallopian Tube Cancer AJCC v7
- Stage IVA Uterine Sarcoma AJCC v7
- Stage IIA Uterine Sarcoma AJCC v7
- Stage IIB Fallopian Tube Cancer AJCC v6 and v7
- Stage IIA Fallopian Tube Cancer AJCC v6 and v7
- Stage IB Ovarian Cancer AJCC v6 and v7
- Stage IIC Fallopian Tube Cancer AJCC v6 and v7
- Stage IVB Uterine Sarcoma AJCC v7
- Stage IIB Ovarian Cancer AJCC v6 and v7
- Stage IIC Ovarian Cancer AJCC v6 and v7
- Stage IIIB Uterine Sarcoma AJCC v7
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVES: I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior death rate when compared to ifosfamide, mesna, and paclitaxel chemotherapy. SECONDARY OBJECTIVES: I. To determine if treatment with combination paclitaxel and...
PRIMARY OBJECTIVES: I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior death rate when compared to ifosfamide, mesna, and paclitaxel chemotherapy. SECONDARY OBJECTIVES: I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior progression-free survival when compared to ifosfamide, mesna, and paclitaxel chemotherapy. II. To determine if acute toxicity, specifically physician-assessed neurotoxicity and infection, associated with combination paclitaxel and carboplatin chemotherapy is reduced compared to that of ifosfamide, mesna, and paclitaxel chemotherapy. III. To determine if treatment with combination paclitaxel and carboplatin chemotherapy is associated with superior patient-reported quality of life and neurotoxicity scores compared to that of ifosfamide, mesna, and paclitaxel chemotherapy. TERTIARY OBJECTIVES: I. To bank formalin-fixed, paraffin-embedded (FFPE) tumor tissue and deoxyribonucleic acid (DNA) extracted from whole blood for future research. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours followed by carboplatin IV over 30-60 minutes on day 1. ARM II: Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I. In both arms, treatment repeats every 21 days for 6-10 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Tracking Information
- NCT #
- NCT00954174
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Matthew A Powell NRG Oncology
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