Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
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.
|Colorectal Cancer Quality of Life||Biological: cetuximab Procedure: quality-of-life assessment||Phase 3|
|Study Design:||Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- 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
|Study Start Date:||August 2003|
|Study Completion Date:||February 2009|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079066
Hide Study Locations
|Australia, New South Wales|
|NHMRC Clinical Trials Centre|
|Camperdown, New South Wales, Australia, 1450|
|Cross Cancer Institute at University of Alberta|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|British Columbia Cancer Agency - Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|Fraser Valley Cancer Centre at British Columbia Cancer Agency|
|Surrey, British Columbia, Canada, V3V 1Z2|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|British Columbia Cancer Agency - Vancouver Island Cancer Centre|
|Victoria, British Columbia, Canada, V8R 6V5|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|Canada, New Brunswick|
|Moncton, New Brunswick, Canada, E1C 6ZB|
|Saint John Regional Hospital|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Canada, Newfoundland and Labrador|
|Newfoundland Cancer Treatment and Research Foundation|
|St. Johns, Newfoundland and Labrador, Canada, A1B 3V6|
|Canada, Nova Scotia|
|Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|Belleville General Hospital|
|Belleville, Ontario, Canada, K8N 5K5|
|Cancer Centre of Southeastern Ontario at Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 5P9|
|Grand River Regional Cancer Centre at Grand River Hospital|
|Kitchner, Ontario, Canada, N2G 1G3|
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada, N6A 4L6|
|R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa|
|Oshawa, Ontario, Canada, L1G 2B9|
|Ottawa Hospital Regional Cancer Centre - General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Hotel Dieu Health Sciences Hospital - Niagara|
|St. Catharines, Ontario, Canada, L2R 5K3|
|Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre|
|Thunder Bay, Ontario, Canada, P7B 6V4|
|Toronto East General Hospital|
|Toronto, Ontario, Canada, M4C 3E7|
|Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|St. Michael's Hospital - Toronto|
|Toronto, Ontario, Canada, M5B 1W8|
|Mount Sinai Hospital - Toronto|
|Toronto, Ontario, Canada, M5G 1X5|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|St. Joseph's Health Centre - Toronto|
|Toronto, Ontario, Canada, M6R 1B5|
|Windsor Regional Cancer Centre at Windsor Regional Hospital|
|Windsor, Ontario, Canada, N8W 2X3|
|Canada, Prince Edward Island|
|Prince Edward Island Cancer Centre at Queen Elizabeth Hospital|
|Charlottetown, Prince Edward Island, Canada, C1A 8T5|
|Hopital Charles Lemoyne|
|Greenfield Park, Quebec, Canada, J4V 2H1|
|Centre Hospitalier de l'Universite de Montreal|
|Montreal, Quebec, Canada, H2L 4MI|
|McGill Cancer Centre at McGill University|
|Montreal, Quebec, Canada, H2W 1S6|
|Hopital Du Sacre-Coeur de Montreal|
|Montreal, Quebec, Canada, H4J 1C5|
|Allan Blair Cancer Centre at Pasqua Hospital|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Saskatoon Cancer Centre at the University of Saskatchewan|
|Saskatoon, Saskatchewan, Canada, S7N 4H4|
|Study Chair:||Derek Jonker, MD||Ottawa Regional Cancer Centre|
|Study Chair:||Chris Karapetis, MD||National Health and Medical Research Council, Australia|