UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

• Status: Completed
• Trial end date: 1969-12-31
• 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. Topotecan may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with topotecan may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: National Cancer Institute (NCI)
• Treatments: 7-hydroxystaurosporine; Staurosporine; Topotecan

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