Flavopiridol in Treating Patients With Recurrent Prostate Cancer

This study has been completed.

First Received: November 1, 1999 Last Updated: July 23, 2008 History of Changes

Sponsors and Collaborators:	University of Wisconsin, Madison National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003256

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent prostate cancer after hormone therapy.

Condition	Intervention	Phase
Prostate Cancer	Drug: alvocidib	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Alvocidib Flavopiridol

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 1998

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.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: ECOG 0-2 Life Expectancy: At least 3 months Hematopoietic: 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 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: 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: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No prior suramin therapy Endocrine 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 Radiotherapy: At least 4 weeks since prior radiotherapy No prior strontium therapy Surgery: Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003256

Locations

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

University of Wisconsin, Madison

National Cancer Institute (NCI)

Investigators

Study Chair:

George Wilding, MD

University of Wisconsin, Madison

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000066145, WCCC-CO-9781, NCI-T97-0038
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003256 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage IV prostate cancer

Study placed in the following topic categories:

Flavopiridol
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

Adenocarcinoma
Protein Kinase Inhibitors
Prostatic Neoplasms
Recurrence
Androgens

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Urogenital Neoplasms
Enzyme Inhibitors
Genital Diseases, Male

Protein Kinase Inhibitors
Pharmacologic Actions
Flavopiridol
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009