Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically\* or cytologically confirmed unresectable gynecologic malignancy for which standard curative or palliative care is not available
• * All tumor types allowed NOTE: \*Histologic confirmation of recurrence is not required
• Measurable or nonmeasurable disease
• * If CT scan was used to evaluate measurable disease, lesions must be clearly defined and be ≥ 10 mm on spiral CT scan
• No "borderline tumors" or tumors with low malignant potential
• PATIENT CHARACTERISTICS:
• Karnofsky performance status 60-100%
• Life expectancy ≥ 12 weeks
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 9 g/dL
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Creatinine clearance ≥ 60 mL/min
• AST/ALT ≤ 2.5 times ULN (\< 5 times ULN if liver metastases are present)
• Alkaline phosphatase ≤ 2.5 times ULN (\< 5 times ULN if liver metastases are present)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Adequate intestinal function (i.e., no gastrostomy tube or requirement for IV hydration or nutritional support)
• No severe gastrointestinal bleeding or intestinal obstruction
• No other condition that would affect gastrointestinal absorption and motility
• No septicemia, severe infection, or acute hepatitis
• No other malignancies requiring chemotherapy or radiotherapy within the past 5 years, except skin cancer
• No concurrent severe medical problem unrelated to the malignancy that would significantly limit full compliance with the study, expose the patient to extreme risk, or decrease life expectancy
• PRIOR CONCURRENT THERAPY:
• At least 28 days since prior investigational drugs (including cytotoxic drugs)
• At least 4 weeks since prior chemotherapy, radiotherapy, biologic therapy, or surgery and recovered
• No more than 3 prior chemotherapy regimens
• No prior topotecan hydrochloride or other camptothecin analogs
• No prior radiotherapy to \> 25% of the bone marrow
• No other concurrent chemotherapy, radiotherapy, biologic therapy, immunotherapy, or hormonal therapy for cancer
• No concurrent administration of any of the following:
• * P-glycoprotein (ABCB1, Pgp, MDR1) inhibitors or inducers
• * Breast cancer-resistant protein (ABCG2, BCRP, MXR) inhibitors or inducers
• No concurrent chronic H2 antagonists, proton pump inhibitors, or antacids for gastritis, gastroesophageal reflux disease, or gastric or duodenal ulcers
• * Intermittent antacid therapy is allowed provided it is given ≥ 6 hours prior to and ≥ 90 minutes after study drug administration