Ovarian Cancer Clinical Trial
Official title:
A Phase II Study of Docetaxel and Carboplatin for Suboptimally Debulked Stage III or Stage IV Ovarian and Fallopian Tube Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in
treating patients who have stage III or stage IV ovarian cancer, fallopian tube cancer, or
primary peritoneal cancer.
OBJECTIVES:
- Evaluate the response rate, duration of response, and progression-free and overall
survival of previously untreated patients with suboptimally debulked stage III or stage
IV ovarian carcinoma, fallopian tube carcinoma, papillary serous cancer of the uterus,
or primary peritoneal carcinoma treated with docetaxel and carboplatin.
- Evaluate the feasibility and toxicity of this regimen in these patients.
- Evaluate the effect of this regimen on quality of life of these patients.
OUTLINE: This is an open-label study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
Quality of life is assessed prior to therapy and then after every 3 courses of chemotherapy.
PROJECTED ACCRUAL: Approximately 14-40 patients will be accrued for this study within 2.5
years.
;
Masking: Open Label, Primary Purpose: Treatment
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