Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube 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.
|Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer||Drug: oxaliplatin Drug: topotecan hydrochloride||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||August 2000|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006391
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Howard S. Hochster, MD||New York University School of Medicine|