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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells.

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

• Phase: Phase 2
• 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 ovarian epithelial, primary peritoneal, or fallopian tube cancer

• Progressive, persistent, or recurrent disease

• Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy

• Tumor lesions accessible for biopsy

• Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator

• No more than 2 prior chemotherapy regimens

• At least 1 regimen must have contained a platinum agent (i.e., 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 history of coronary artery disease

• No symptomatic cardiac dysfunction

• No cardiac pathology by electrocardiogram* NOTE: *Patients with symptomatic coronary artery disease must undergo an electrocardiogram

Pulmonary

• No symptomatic pulmonary dysfunction

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 8 weeks after study participation

• No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents

• No insulin-dependent diabetes mellitus

• Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator

• No other concurrent uncontrolled illness

• No ongoing or active infection

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 weeks since prior biologic therapy and recovered

Chemotherapy

• See Disease Characterisitcs

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• No prior topotecan

• No other prior topoisomerase I inhibitors

Endocrine therapy

• More than 4 weeks since prior hormonal therapy and recovered

Radiotherapy

• See Disease Characteristics

• More than 4 weeks since prior radiotherapy and recovered

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

• No prior mediastinal irradiation

Surgery

• More than 4 weeks since prior surgery and recovered

Other

• No other concurrent anticancer therapy

• No other concurrent investigational agents

• No concurrent combination antiretroviral therapy for HIV-positive patients