Spots Global Cancer Trial Database for ISIS 2503 in Treating Patients With Metastatic and/or Locally Recurrent Colorectal Cancer
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Trial Identification
Brief Title: ISIS 2503 in Treating Patients With Metastatic and/or Locally Recurrent Colorectal Cancer
Official Title: Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-ras, in Patients With Advanced Colorectal Cancer
Study ID: NCT00004193
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: ISIS 2503 may kill cancer cells by inhibiting a gene that promotes the development and growth of cancer. PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have metastatic and/or locally recurrent colorectal cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States
Contact Details
Name: Mansoor N. Saleh, MD
Affiliation: University of Alabama at Birmingham
Role: STUDY_CHAIR
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