Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00079066|
Recruitment Status : Completed
First Posted : March 9, 2004
Last Update Posted : November 1, 2013
RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Best supportive care is the use of drugs and other treatments to improve the quality of life of patients. Combining cetuximab with best supportive care may slow the growth of the tumor and help patients live longer and more comfortably. It is not yet known whether cetuximab combined with best supportive care is more effective than best supportive care alone in treating metastatic epidermal growth factor receptor-positive colorectal cancer.
PURPOSE: This randomized phase III trial is studying cetuximab and best supportive care to see how well they work compared to best supportive care alone in treating patients with metastatic epidermal growth factor receptor-positive colorectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Quality of Life||Biological: cetuximab Procedure: quality-of-life assessment||Phase 3|
- Compare survival of patients with metastatic epidermal growth factor receptor-positive colorectal cancer treated with cetuximab and best supportive care vs best supportive care alone.
- Compare the time to disease progression in patients treated with these regimens.
- Compare the objective response rate in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the health utilities of patients treated with these regimens.
- Conduct a comparative economic evaluation in patients treated with these regimens.
- Determine the safety profile of cetuximab in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive an initial loading dose of cetuximab IV over 120 minutes on day 1. Patients continue to receive maintenance infusions of cetuximab IV over 60 minutes weekly. Patients also receive best supportive care, defined as measures designed to provide palliation of symptoms and improve quality of life as much as possible.
- Arm II: Patients receive best supportive care as in arm I. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, and then at 4, 8, 16, and 24 weeks (or until deterioration to ECOG PS 4 or hospitalization for end-of-life care).
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 20 months.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Randomized Study of Cetuximab (Erbitux™, C225) and Best Supportive Care Versus Best Supportive Care in Patients With Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Positive Colorectal Carcinoma|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||February 2009|
- Overall survival
- Time to progression
- Objective response rate
- Quality of life by European Organization for Research of the Treatment of Cancer Quality of Life Questionnaire -C30 (EORTC QLQ-C30)
- Health utilities by Health Utilities Index 13 (HU 13)
- Economic evaluation
- Safety profile
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079066
Show 33 Study Locations
|Study Chair:||Derek Jonker, MD||Ottawa Regional Cancer Centre|
|Study Chair:||Chris Karapetis, MD||National Health and Medical Research Council, Australia|