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
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.
DISEASE CHARACTERISTICS: Histologically documented epithelial ovarian carcinoma or
fallopian tube cancer or primary peritoneal cancer following initial cytoreductive surgery
and chemotherapy with at least one cisplatin based chemotherapy regimen Must have
undergone a second assessment procedure (laparoscopy or laparotomy) within 8 weeks of
protocol entry, and have confirmation of residual disease no greater than 1.0 cm at the
end of the procedure
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 3 times upper limit of normal (ULN) SGOT less
than 3 times ULN Alkaline phosphatase less than 3 times ULN Renal: Creatinine less than
1.6 mg/dL Creatinine clearance at least 50 mL/min Other: Must have a functioning implanted
subcutaneous intraperitoneal catheter No neuropathy of grade III or greater from prior
chemotherapy No contraindication to intraperitoneal therapy e.g., intraabdominal infection
or widespread adhesions
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See