ISIS 2503 in Treating Patients With Metastatic and/or Locally Recurrent Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00004193|
Recruitment Status : Terminated
First Posted : August 5, 2004
Last Update Posted : April 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: ISIS 2503||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-ras, in Patients With Advanced Colorectal Cancer|
|Study Start Date :||January 1999|
|Primary Completion Date :||November 2000|
|Study Completion Date :||November 2000|
Experimental: ISIS 2503
patients who have metastatic and/or locally recurrent colorectal cancer
|Drug: ISIS 2503|
- 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 [ Time Frame: baseline to survival ]
- Determine the safety profile of this regimen in these patients. [ Time Frame: Baseline to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004193
|United States, Alabama|
|University of Alabama Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|Study Chair:||Mansoor N. Saleh, MD||University of Alabama at Birmingham|