Phase II Trial of Weekly Docetaxel (Taxotere®) and Carboplatin as Initial Chemotherapy for Women With Ovarian Cancer and Similar Malignancies
- 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.
- 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.
Masking: Open Label, Primary Purpose: Treatment
Reduction rate of myelosuppression
Howard G. Muntz, MD
Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center
United States: Federal Government
|Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center||Seattle, Washington 98111|