Ovarian Cancer Clinical Trial
Official title:
Phase I Trial Intraperitoneal Cisplatin With Intraperitoneal Gemcitabine in Patients With Epithelial Ovarian 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 cisplatin plus gemcitabine in treating
patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary
peritoneal cancer.
OBJECTIVES: I. Determine the maximum tolerated dose of intraperitoneal (IP) gemcitabine
given in combination with IP cisplatin in patients with refractory or recurrent ovarian
epithelial, fallopian tube, or primary peritoneal cancer. II. Determine the safety of this
regimen in this patient population. III. Determine the pharmacokinetics of IP gemcitabine
administered with IP cisplatin.
OUTLINE: This is a dose escalation study of gemcitabine. Patients receive intraperitoneal
cisplatin on day 1 plus intraperitoneal gemcitabine on days 1, 8, and 15. No treatment will
be given on day 22. Courses are repeated every 4 weeks. Patients receive up to 4 courses of
therapy. Dose escalation of gemcitabine continues in cohorts of 3 patients until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2
of 6 patients experience dose limiting toxicity (DLT). Patients are followed every 3 months
for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study.
;
Primary Purpose: Treatment
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