Flavopiridol in Treating Patients With Recurrent Prostate Cancer

February 8, 2013 updated by: National Cancer Institute (NCI)

A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Beckman Research Institute, City of Hope
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: alvocidib

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Primary Completion (Actual)

July 1, 2002

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 30, 2004

First Posted (Estimate)

August 2, 2004

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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