Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00039273|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 8, 2013
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory metastatic colorectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: panitumumab||Phase 2|
- Determine the response rate of patients with metastatic colorectal cancer treated with monoclonal antibody ABX-EGF.
- Determine the additional measures of clinical efficacy of this drug, in terms of progression-free survival, overall survival, and time to treatment failure, in these patients.
- Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour weekly on weeks 1-8. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Official Title:||An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||May 2003|
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): NCT00039273
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Joel Randolph Hecht, MD||Jonsson Comprehensive Cancer Center|