NCT00005833

S9923 R115777 in Treating Patients With Advanced Colorectal Cancer

A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• 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 recurrent or advanced colorectal cancer.

Detailed description

OBJECTIVES: I. Determine the response rate to R115777 in patients with disseminated colorectal cancer who have been previously treated for advanced disease. II. Assess the time to treatment failure and survival of these patients with this treatment regimen. III. Determine the frequency and severity of toxicities of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral R115777 twice daily on days 1-21. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-7 months.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	R115777	300mg P.O. BID.

Timeline

• Start date: 2000-06-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2004-04-12
• Last updated: 2012-06-14

Locations

12 sites across 1 country: United States