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
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.
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage III or IV ovarian
epithelial cancer Platinum resistant disease as defined by disease progression during or
within 6 months of receiving prior paclitaxel combined with cisplatin or carboplatin No
elevated CA-125 as only evidence of disease recurrence Measurable disease At least 20 mm
in diameter by conventional techniques OR At least 10 mm in diameter by spiral CT scan No
known brain metastases
PATIENT CHARACTERISTICS: Age: 21 and over Performance status: ECOG 0-2 Life expectancy:
Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at
least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST and ALT
no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine
clearance greater than 60 mL/min Other: No history of allergic reactions to compounds of
similar chemical or biologic composition to rebeccamycin analogue No other prior cancer
within the past 5 years except nonmelanomatous skin cancer No other medical problems that
would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent therapeutic
agents for cancer