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Flavopiridol in Treating Patients With Recurrent Prostate Cancer

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: February 8, 2013
Last verified: January 2013
Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent prostate cancer after hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Condition Intervention Phase
Prostate Cancer
Drug: alvocidib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Enrollment: 40
Study Start Date: May 1998
Study Completion Date: April 2004
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: alvocidib

Detailed Description:


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.


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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00003256

United States, California
Beckman Research Institute, City of Hope
Duarte, California, United States, 91010
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: George Wilding, MD University of Wisconsin, Madison
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00003256     History of Changes
Other Study ID Numbers: CDR0000066145
Study First Received: November 1, 1999
Last Updated: February 8, 2013

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017