Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.


Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Study Chair: George Wilding, MD University of Wisconsin, Madison
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00003256     History of Changes
Other Study ID Numbers: CDR0000066145, WCCC-CO-9781, NCI-T97-0038
Study First Received: November 1, 1999
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on February 27, 2015