NCT00005848

R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Phase II Trial of R115777 (NSC 702818) an Inhibitor of Farnesyl Protein Transferase, in Patients With Hormone Refractory Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	chemotherapy
DRUG	tipifarnib

Timeline

• Start date: 2000-04-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2004-03-16
• Last updated: 2013-07-11

Locations

2 sites across 1 country: United States