- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00072267
UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Margaret and Charles Juravinski Cancer Centre
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London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hal W. Hirte, MD, FRCP(C), Margaret and Charles Juravinski Cancer Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Topoisomerase I Inhibitors
- Topotecan
- 7-hydroxystaurosporine
Other Study ID Numbers
- PMH-PHL-019
- CDR0000339563 (Registry Identifier: PDQ (Physician Data Query))
- NCI-6402
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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