Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-ras, in Patients With Advanced Colorectal Cancer
OBJECTIVES: I. Determine the response rate, duration of response, and time to progression in
patients with metastatic and/or locally recurrent adenocarcinoma of the colon or rectum
treated with ISIS 2503, an antisense inhibitor of H-ras. II. Determine the safety profile of
this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive ISIS 2503 IV continuously for 14
days. Courses repeat every 3 weeks in the absence of disease progression or unacceptable
toxicity.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study within 1 year.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the response rate, duration of response, and time to progression in patients with metastatic and/or locally recurrent adenocarcinoma of the colon or rectum treated with ISIS 2503, an antisense inhibitor of H-ras
baseline to survival
No
Mansoor N. Saleh, MD
Study Chair
University of Alabama at Birmingham
United States: Federal Government
CDR0000067434
NCT00004193
January 1999
November 2000
Name | Location |
---|---|
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |