S9923 R115777 in Treating Patients With Advanced Colorectal Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Colorectal Cancer|
- Confirmed complete and partial response rate to R115777 [ Time Frame: Once every 8 weeks until progression ] [ Designated as safety issue: No ]Confirmed complete and partial response rate to R115777 in pts with measurable, disseminated colorectal cancer and no prior therapy for advanced disease.
- Time to treatment failure and survival [ Time Frame: Once every 8 weeks until progression, then once every 6 months for 2 years, then annually until 3 years from registration ] [ Designated as safety issue: No ]To assess time to treatment failure and survival in this group of patients.
- Frequency & severity of toxicities [ Time Frame: Weekly for 8 weeks and then once every 4 weeks until progression ] [ Designated as safety issue: Yes ]To assess the frequency and severity of toxicities associated with this treatment.
|Study Start Date:||June 2000|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
R115777, 300mg PO BID on Days 1-21. 1 cycle=28 days.
300mg P.O. BID.
Other Name: NSC-702818
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.
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033-0800|
|Veterans Affairs Outpatient Clinic - Martinez|
|Martinez, California, United States, 94553|
|University of California Davis Medical Center|
|Sacramento, California, United States, 95817|
|United States, Illinois|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|Veterans Affairs Medical Center - Wichita|
|Wichita, Kansas, United States, 67218|
|United States, Missouri|
|CCOP - Kansas City|
|Kansas City, Missouri, United States, 64131|
|United States, Montana|
|CCOP - Montana Cancer Consortium|
|Billings, Montana, United States, 59101|
|United States, Ohio|
|CCOP - Columbus|
|Columbus, Ohio, United States, 43206|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|United States, Washington|
|CCOP - Northwest|
|Tacoma, Washington, United States, 98405-0986|
|Study Chair:||Robert P. Whitehead, MD||University of Texas|