R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
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 R115777 in treating patients who have progressive, metastatic prostate cancer that has not responded to hormone therapy.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Phase II Trial of R115777 (NSC 702818) an Inhibitor of Farnesyl Protein Transferase, in Patients With Hormone Refractory Prostate Cancer|
|Study Start Date:||April 2000|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine whether R115777 has any antitumor activity in patients with progressive, metastatic, hormone refractory prostate cancer. II. Determine the safety and pharmacokinetics of this regimen in this patient population.
OUTLINE: Patients receive oral R115777 every 12 hours on days 1-21. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 10-16 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005848
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Study Chair:||Gary R. Hudes, MD||Fox Chase Cancer Center|