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

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00005848
• Lead Sponsor: Fox Chase Cancer Center

Brief 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.

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2000-06-02
• Study First Submitted QC: 2004-03-15
• Study First Posted: 2004-03-16
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (2)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Cleveland Clinic Taussig Cancer Center; 🇺🇸 Cleveland, Ohio, United States