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Flavopiridol in Treating Patients With Recurrent Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
alvocidib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Beckman Research Institute, City of Hope
  • University of California Davis Cancer Center
  • Dana-Farber Cancer Institute
  • University of Wisconsin Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003256
Brief Title
Flavopiridol in Treating Patients With Recurrent Prostate Cancer
Official Title
A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
July 2002 (Actual)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
alvocidib

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Wilding, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
Beckman Research Institute, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14871968
Citation
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.
Results Reference
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Flavopiridol in Treating Patients With Recurrent Prostate Cancer

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