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A Phase 2 Study of BMY-27557-14 (a Rebeccamycin Analog) in Patients With Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating patients who have refractory stage III or stage IV ovarian epithelial cancer.
OBJECTIVES: I. Determine the response rate to rebeccamycin analogue in patients with refractory stage III or IV ovarian epithelial cancer who have failed platinum in combination with paclitaxel chemotherapy. II. Determine the toxicities of this treatment regimen in these patients. OUTLINE: Patients receive rebeccamycin analogue IV over 60 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients with complete response after receiving 3 courses receive 3-6 additional courses. Patients with partial response or stable disease after receiving 3 courses receive 3-12 additional courses. Patients with complete response are followed every 2 months for 2 years, and then every 3 months thereafter. All other patients are followed every 3 months. PROJECTED ACCRUAL: A total of 18-39 patients will be accrued for this study.
Age
21 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Start Date
July 1, 2000
Primary Completion Date
September 1, 2001
Completion Date
September 1, 2001
Last Updated
June 11, 2012
becatecarin
DRUG
Lead Sponsor
Northwestern University
Collaborators
NCT05039801
NCT04550494
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