Ovarian Cancer Clinical Trial
Official title:
A Phase I Feasibility Trial of Carboplatin, Paclitaxel, and Gemcitabine in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal 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 I trial to study the effectiveness of combination chemotherapy in treating
patients with previously untreated stage III or stage IV ovarian or primary peritoneal
cancer.
OBJECTIVES: I. Determine the feasibility of administering multiple courses of chemotherapy
without excessive dose modification or treatment delay in patients with previously untreated
ovarian epithelial carcinoma or primary peritoneal carcinoma. II. Determine the response
rate (in patients with measurable disease) and progression-free interval in these patients
receiving this treatment.
OUTLINE: This is a feasibility study. On day 1, patients receive paclitaxel as a 3 hour
continuous IV infusion followed by carboplatin as a 30 minute infusion. Gemcitabine is
administered by continuous infusion over 30 minutes on day 1 following carboplatin and on
day 8. In the absence of disease progression or unacceptable toxicity, courses repeat every
21 days for a maximum of 8 courses. Patients are followed every 3 months for 2 years, every
6 months for the next 3 years, and annually thereafter.
PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within
approximately 2 years.
;
Primary Purpose: Treatment
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