NCT00006391

Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

A Phase I Dose-Finding Study of Oxaliplatin (NSC #266046) Combined With Continuous Infusion Topotecan Hydrochloride as Chemotherapy for Patients With Previously Treated Ovarian Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 combining oxaliplatin with topotecan in treating patients who have previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose and dose-limiting toxic effects of oxaliplatin and topotecan in patients with previously treated ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. * Determine the qualitative and quantitative toxic effects of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. * Determine the antitumor activity of this treatment regimen in these patients. * Determine the correlation between the pharmacokinetic and safety data of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with measurable disease who achieve a response may receive additional therapy at the discretion of the principal investigator. Cohorts of 3-6 patients receive escalating doses of oxaliplatin and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed through day 30. PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	oxaliplatin
DRUG	topotecan hydrochloride

Timeline

• Start date: 2000-08-01
• Primary completion: 2004-11-01
• First posted: 2003-01-27
• Last updated: 2011-04-05

Locations

1 site across 1 country: United States