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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
300mg P.O. BID.
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
University of California Davis Medical Center
Sacramento, California, United States
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.
Time frame: Once every 8 weeks until progression
Time to treatment failure and survival
To assess time to treatment failure and survival in this group of patients.
Time frame: Once every 8 weeks until progression, then once every 6 months for 2 years, then annually until 3 years from registration
Frequency & severity of toxicities
To assess the frequency and severity of toxicities associated with this treatment.
Time frame: Weekly for 8 weeks and then once every 4 weeks until progression
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CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Greenville
Greenville, South Carolina, United States
...and 2 more locations