Cisplatin and Gemcitabine in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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chemotherapy

Intervention Type DRUG

cisplatin

Intervention Type DRUG

gemcitabine hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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 Disease Characteristics

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No