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Flavopiridol in Treating Patients With Recurrent Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003256
First received: November 1, 1999
Last updated: February 8, 2013
Last verified: January 2013
History of Changes

November 1, 1999
February 8, 2013
May 1998
July 2002   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00003256 on ClinicalTrials.gov Archive Site
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Flavopiridol in Treating Patients With Recurrent Prostate Cancer
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.

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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: alvocidib
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.
Intervention: Drug: alvocidib
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2004
July 2002   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003256
CDR0000066145, WCCC-CO-9781, NCI-T97-0038
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: George Wilding, MD University of Wisconsin, Madison
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP