Clinical Trials

Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine or Ovarian Cancer

Location:

Rochester, MN, Scottsdale and Phoenix, AZ, Jacksonville, FL

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES: Primary - To determine if treatment with paclitaxel and carboplatin does not result in an inferior death rate when compared to paclitaxel and ifosfamide in chemotherapy-naïve patients with newly diagnosed stage I-IV persistent or recurrent uterine or ovarian carcinosarcoma. Secondary - To determine if treatment with combination paclitaxel and carboplatin does not result in an inferior progression-free survival when compared to paclitaxel and ifosfamide. - To determine if acute toxicity, specifically physician-assessed neurotoxicity and infection, associated with combination paclitaxel and carboplatin is reduced compared to that of paclitaxel and ifosfamide. - To determine if treatment with combination paclitaxel and carboplatin is associated with superior patient reported quality of life and neurotoxicity scores compared to that of paclitaxel and ifosfamide. Tertiary - To bank formalin-fixed and paraffin-embedded tumor tissue and DNA extracted from whole blood specimens for future research. OUTLINE: Patients are stratified according to history of pelvic radiation (any vs none), disease status/stage at time of study registration (stage I-II [pelvic lymph nodes not surgically and pathologically assessed] vs FIGO stage I-II [pelvic lymph nodes surgically and pathologically assessed] vs FIGO stage III-IV vs recurrent), and measurable disease (any vs none). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. - Arm II: Patients receive paclitaxel as in arm I and ifosfamide IV over 1 hour on days 1-3. In both arms, treatment repeats every 21 days for 6-10 courses in the absence of disease progression or unacceptable toxicity. Archival formalin-fixed and paraffin-embedded tumor tissue samples and a pre-treatment blood sample are collected for further analysis. Patients also complete quality of life (FACT-G, FACT-En TOI) and neurotoxicity (FACT/GOG-Ntx subscale) assessments at baseline and at weeks 6, 15, and 26. 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.

Last updated: 05/02/2012

NCT ID:

NCT00954174