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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00072267
• Other study ID #: PMH-PHL-019
• Secondary ID: CDR0000339563NCI
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2003
• Last updated: July 22, 2015
• Start date: January 2004

Study information

• Verified date: July 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• 7-hydroxystaurosporine

• topotecan hydrochloride

Locations

Country	Name	City	State
Canada	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

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	National Cancer Institute (NCI)

Country where clinical trial is conducted

Canada,