ZD9331 With or Without Topotecan in Treating Patients With Refractory or Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining two or more drugs may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of different regimens of ZD9331 with or without topotecan in treating patients who have refractory or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Topotecan; ZD 9331

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