Phase II Trial of Weekly Docetaxel (Taxotere®) and Carboplatin as Initial Chemotherapy for Women With Ovarian Cancer and Similar Malignancies

Brief Summary

Detailed Description

OBJECTIVES: Primary * Determine whether weekly administration of docetaxel and carboplatin is safer than conventional three-week chemotherapy courses, in terms of reducing the rate of myelosuppression, in patients with stage IC-IV ovarian epithelial, fallopian tube, or peritoneal cavity cancer. Secondary * Determine the quality of life of patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. * Determine the efficacy of this regimen, in terms of clinical response rate, time to disease progression, and findings at second-look surgery, in these patients. OUTLINE: Patients receive docetaxel IV and carboplatin IV on days 1, 8, 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then undergo optional second-look surgery. After completion of 6 courses of chemotherapy (and second-look surgery, if applicable), patients may receive consolidation and/or salvage therapy at the discretion of the investigator. Quality of life is assessed at baseline, before each treatment course, at the completion of study treatment, and then annually for 2 years. After completion of study treatment, patients are followed annually for 2 years. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.

Primary Outcomes

Secondary Outcomes

• Clinical response rate
• Findings at second look surgery
• Time to disease progression
• Quality of life as assessed by the Functional Assessment of Cancer Therapy -Ovarian (FACT-O) questionnaire
• Toxicity