Flavopiridol in Treating Patients With Recurrent 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 Design:||Intervention Model: Single Group Assignment
Masking: 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 1998|
|Study Completion Date:||April 2004|
|Primary Completion Date:||July 2002 (Final data collection date for primary outcome measure)|
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.
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.
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.
|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|
|Study Chair:||George Wilding, MD||University of Wisconsin, Madison|