S9923 R115777 in Treating Patients With Advanced Colorectal Cancer
- Registration Number
- NCT00005833
- Lead Sponsor
- SWOG Cancer Research Network
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description R115777 R115777 R115777, 300mg PO BID on Days 1-21. 1 cycle=28 days.
- Primary Outcome Measures
Name Time Method Confirmed complete and partial response rate to R115777 Once every 8 weeks until progression Confirmed complete and partial response rate to R115777 in pts with measurable, disseminated colorectal cancer and no prior therapy for advanced disease.
- Secondary Outcome Measures
Name Time Method Time to treatment failure and survival Once every 8 weeks until progression, then once every 6 months for 2 years, then annually until 3 years from registration To assess time to treatment failure and survival in this group of patients.
Frequency & severity of toxicities Weekly for 8 weeks and then once every 4 weeks until progression To assess the frequency and severity of toxicities associated with this treatment.
Trial Locations
- Locations (12)
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States