A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed recurrent ovarian epithelial, fallopian
tube, or primary peritoneal cavity cancer

- Measurable disease outside of field of prior radiotherapy OR

- Progressive disease within field after radiotherapy

- Must have had no more than 2 prior chemotherapy regimens

- At least 1 prior regimen must have included a platinum agent (e.g., carboplatin
or cisplatin)

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- More than 12 weeks

Hematopoietic

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

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

Hepatic

- Bilirubin no greater than upper limit of normal (ULN)

- AST/ALT no greater than 2.5 times ULN

Renal

- Creatinine no greater than ULN OR

- Creatinine clearance at least 50 mL/min

Cardiovascular

- No coronary artery disease

- No symptomatic cardiac dysfunction

- No symptoms suggestive of coronary artery disease with evidence of cardiac pathology

Pulmonary

- No symptomatic pulmonary dysfunction

Other

- No prior allergic reaction attributed to compounds of similar chemical or biologic
composition to UCN-01 or other agents used in this study

- No insulin-dependent diabetes mellitus

- No other uncontrolled concurrent illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 4 weeks since prior biologic therapy

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

- No prior topotecan (other prior topoisomerase I inhibitors allowed)

Endocrine therapy

- At least 4 weeks since prior hormonal therapy

Radiotherapy

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- No prior radiotherapy to more than 40% of bone marrow

- No prior mediastinal irradiation

Surgery

- At least 4 weeks since prior surgery

Other

- Recovered from all prior therapy

- No other concurrent investigational agents

- No other concurrent anticancer agents or therapies

- No concurrent combination antiretroviral therapy for HIV-positive patients