Ovarian Cancer Clinical Trial
Official title:
A Phase I Study of Docetaxel (Taxotere), Carboplatin, and Gemcitabine (DoCaGem) as First-Line Therapy for Patients With High-Risk Epithelial Tumors of Mullerian Origin
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 I trial to study the effectiveness of combining docetaxel, carboplatin, and
gemcitabine in treating patients who have previously untreated, newly diagnosed epithelial
cancer.
OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel, carboplatin, and
gemcitabine in patients with previously untreated, newly diagnosed, high-risk epithelial
cancer of mullerian origin.
OUTLINE: This is a dose-escalation study of docetaxel and gemcitabine. Patients receive
docetaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Carboplatin
IV is administered over 30 minutes on day 1. Treatment repeats every 21-28 days for up to 6
courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5
patients receive escalating doses of docetaxel and gemcitabine until the maximum tolerated
dose is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5
patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 1.5-2
years.
;
Primary Purpose: Treatment
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