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

Phase 1

Completed

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

• Registration Number: NCT00003358
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1998-01
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-01
• Study First Submitted QC: 2004-07-30
• Study First Posted: 2004-08-02
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States