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Flavopiridol in Treating Patients With Recurrent Prostate Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00003256
Collaborator
(none)
40
Enrollment
4
Locations
1
Arm
71
Duration (Months)
10
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  1. Evaluate the clinical effectiveness of flavopiridol in patients with metastatic androgen independent adenocarcinoma of the prostate.

  2. 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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer
Study Start Date :
May 1, 1998
Actual Primary Completion Date :
Jul 1, 2002
Actual Study Completion Date :
Apr 1, 2004

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beckman Research Institute, City of Hope Duarte California United States 91010
    2 University of California Davis Cancer Center Sacramento California United States 95817
    3 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    4 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: George Wilding, MD, University of Wisconsin, Madison

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00003256
    Other Study ID Numbers:
    • CDR0000066145
    • WCCC-CO-9781
    • NCI-T97-0038
    First Posted:
    Aug 2, 2004
    Last Update Posted:
    Feb 11, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by National Cancer Institute (NCI)
    adenocarcinoma of the prostate
    stage IV prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Alvocidib

    Study Results

    No Results Posted as of Feb 11, 2013