Ovarian Cancer Clinical Trial
Official title:
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.
;
Primary Purpose: Treatment
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