A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Colorectal Cancer
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
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-7 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed complete and partial response rate to R115777
Confirmed complete and partial response rate to R115777 in pts with measurable, disseminated colorectal cancer and no prior therapy for advanced disease.
Once every 8 weeks until progression
Robert P. Whitehead, MD
University of Texas
United States: Federal Government
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|University of California Davis Medical Center||Sacramento, California 95817|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|Veterans Affairs Outpatient Clinic - Martinez||Martinez, California 94553|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Montana Cancer Consortium||Billings, Montana 59101|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Greenville||Greenville, South Carolina 29615|
|Veterans Affairs Medical Center - Wichita||Wichita, Kansas 67218|
|CCOP - Northwest||Tacoma, Washington 98405-0986|