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Clinical Trial Summary

This randomized phase III trial studies paclitaxel and carboplatin see how well they work compared with paclitaxel and ifosfamide in treating patients with fallopian tube, or peritoneal cavity cancer that is newly diagnosed, persistent, or has come back (recurrent). Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether paclitaxel is more effective when given with carboplatin or ifosfamide in treating patients with uterine, ovarian, fallopian tube, or peritoneal cavity cancer.


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Carcinosarcoma
  • Fallopian Tube Neoplasms
  • Mixed Mesodermal (Mullerian) Tumor
  • Mixed Tumor, Mullerian
  • Ovarian Carcinosarcoma
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Sarcoma
  • 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

NCT number NCT00954174
Study type Interventional
Source GOG Foundation
Contact
Status Active, not recruiting
Phase Phase 3
Start date August 17, 2009

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