ISIS 2503 in Treating Patients With Metastatic and/or Locally Recurrent Colorectal Cancer
- Registration Number
- NCT00004193
- Lead Sponsor
- University of Alabama at Birmingham
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ISIS 2503 ISIS 2503 patients who have metastatic and/or locally recurrent colorectal cancer
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Determine the safety profile of this regimen in these patients. Baseline to 1 year
Trial Locations
- Locations (1)
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States