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

NCT ID: NCT00072267

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31

Brief 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.

Detailed Description

OBJECTIVES:

Primary

• Determine the antitumor activity of UCN-01 and topotecan, in terms of complete and partial objective response rates, in patients with recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Secondary

• Determine the antitumor activity of this regimen, in terms of stable disease rates and duration of response, in these patients.
• Determine the progression-free, median, and overall survival of patients treated with this regimen.
• Determine the safety and tolerability of this regimen in these patients.
• Determine the relationship between clinical and pharmacodynamic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 5-11 months.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

7-hydroxystaurosporine

Intervention Type: DRUG

topotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hal W. Hirte, MD, FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

Margaret and Charles Juravinski Cancer Centre

Locations

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, Canada

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, Canada

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CDR0000339563

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-6402

Identifier Type: -

Identifier Source: secondary_id

PMH-PHL-019

Identifier Type: -

Identifier Source: org_study_id