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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
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.
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Start Date
August 1, 2000
Primary Completion Date
November 1, 2004
Last Updated
April 5, 2011
oxaliplatin
DRUG
topotecan hydrochloride
DRUG
Lead Sponsor
NYU Langone Health
Collaborators
NCT05039801
NCT04550494
Data Source & Attribution
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