A Phase II, Open, Randomized Multicenter Trial to Assess the Efficacy and Tolerability of Intravenous ZD9331 Given as Monotherapy (at Two Doses) or in Combination With Topotecan, in Patients With Ovarian Cancer Refractory or Recurrent After Failing Platinum and Paclitaxel in Combination

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ovarian epithelial
cancer, primary peritoneal cancer, or fallopian tube cancer Refractory or recurrent
disease after combination platinum and paclitaxel as only prior chemotherapy regimen
Platinum resistant (i.e., refractory or relapsed within 6 months after completion of last
therapy regimen) No more than 2 prior platinum and paclitaxel combination regimens
Measurable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy:
More than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: No unstable or uncompensated hepatic disease Bilirubin less
than 1.25 times upper limit of normal (ULN) Albumin at least lower limit of normal ALT or
AST no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal: No
unstable or uncompensated renal disease Creatinine clearance at least 60 mL/min
Cardiovascular: No unstable or uncompensated cardiac disease Pulmonary: No unstable or
uncompensated respiratory disease Other: No concurrent intestinal obstruction No evidence
of severe or uncontrolled systemic disease No other active malignancy within the past 5
years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix No
severe concurrent condition that would preclude study compliance No risk of transmitting
HIV or hepatitis B or C Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: No prior extensive
radiotherapy to more than 30% of bone marrow (e.g., whole pelvis or half of spine) No
concurrent radiotherapy for ovarian cancer Surgery: At least 2 weeks since prior
surgery,except for insertion of central venous access device, and recovered Other: At
least 4 weeks since other anticancer therapy and recovered Concurrent folic acid in a
nutritional supplement allowed except within the 24 hours before and after ZD9331 dosing
No other concurrent study drugs No other concurrent systemic therapy for ovarian cancer