- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003256
Flavopiridol in Treating Patients With Recurrent Prostate Cancer
A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer
Study Overview
Detailed Description
OBJECTIVES:
I. Evaluate the clinical effectiveness of flavopiridol in patients with metastatic androgen independent adenocarcinoma of the prostate.
II. Assess the toxic effects of flavopiridol in this patient population.
OUTLINE:
Patients receive intravenous flavopiridol over 72 hours every 2 weeks for at least 4 courses. After 2 courses of treatment, patients not experiencing unacceptable toxic effects may receive a dose escalation. Patients are followed every 3 months until death.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Duarte, California, United States, 91010
- Beckman Research Institute, City of Hope
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Sacramento, California, United States, 95817
- University of California Davis Cancer Center
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PATIENT CHARACTERISTICS:
- Performance Status: ECOG 0-2
- Life Expectancy: At least 3 months
- WBC at least 3,000/mm3
- Absolute neutrophil count at least 1,200/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 8 g/dL
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2.5 times normal
- Creatinine no greater than 1.5 mg/dL
- Prostate-specific antigen at least 10 ng/mL (if bone only disease)
- No prior or concurrent maligancies within 5 years, except nonmelanoma skin cancer
- No serious medical illness
- No cord compression symptoms
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No prior suramin therapy
- Prior or concurrent use of luteinizing hormone-releasing hormone allowed (no other concurrent hormonal therapy)
- No prior anti-androgen therapy within 4 weeks of study
- At least 4 weeks since prior radiotherapy
- No prior strontium therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Patients receive intravenous flavopiridol over 72 hours every 2 weeks for at least 4 courses.
After 2 courses of treatment, patients not experiencing unacceptable toxic effects may receive a dose escalation.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study 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
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Alvocidib
Other Study ID Numbers
- CDR0000066145
- WCCC-CO-9781
- NCI-T97-0038
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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