Rebeccamycin Analogue in Treating Patients With Refractory Stage III or Stage IV Ovarian Epithelial 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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase 2 Study of BMY-27557-14 (a Rebeccamycin Analog) in Patients With Ovarian Cancer|
|Study Start Date:||July 2000|
|Study Completion Date:||September 2001|
|Primary Completion Date:||September 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006262
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||David A. Fishman, MD||Robert H. Lurie Cancer Center|