Flavopiridol in Treating Patients With Recurrent Prostate Cancer
NCT ID: NCT00003256
Last Updated: 2013-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
1998-05-31
2004-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
alvocidib
Interventions
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alvocidib
Eligibility Criteria
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Inclusion Criteria
* 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
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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George Wilding, MD
Role: STUDY_CHAIR
University of Wisconsin, Madison
Locations
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Beckman Research Institute, City of Hope
Duarte, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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References
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Liu G, Gandara DR, Lara PN Jr, Raghavan D, Doroshow JH, Twardowski P, Kantoff P, Oh W, Kim K, Wilding G. A Phase II trial of flavopiridol (NSC #649890) in patients with previously untreated metastatic androgen-independent prostate cancer. Clin Cancer Res. 2004 Feb 1;10(3):924-8. doi: 10.1158/1078-0432.ccr-03-0050.
Other Identifiers
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WCCC-CO-9781
Identifier Type: -
Identifier Source: secondary_id
NCI-T97-0038
Identifier Type: -
Identifier Source: secondary_id
CDR0000066145
Identifier Type: -
Identifier Source: org_study_id
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