A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically documented refractory or recurrent ovarian epithelial or fallopian
tube cancer

- No borderline ovarian cancer

- Extra-ovarian papillary serous tumors eligible

- Must not be eligible for any higher priority phase II or III GOG protocol

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- SGOT no greater than 3 times upper limit of normal (ULN)

- Bilirubin no greater than 1.5 mg/dL

- Elevated levels of alkaline phosphatase allowed

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No angina pectoris or clinically significant multifocal uncontrolled cardiac
dysrhythmias

- No uncontrolled hypertension

Other:

- No other active malignancy

- No prior malignancy within the past 5 years except nonmelanomatous skin cancer

- No active infection

- No underlying medical problem that would prevent compliance

- No known hypersensitivity to E. coli-derived drug preparations

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Must have received at least 1 prior platinum- and paclitaxel-based regimen

- At least 4 weeks since prior chemotherapy

- No prior topotecan and/or gemcitabine

- No prior chemotherapy for a different prior malignancy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to more than 10% of bone marrow

- At least 2 weeks since limited field radiation therapy

Surgery:

- Not specified