Cetuximab + Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
Condition: Colorectal Cancer; Quality of Life
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  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.

      Secondary

        -  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.
    

Intervention name(s): cetuximab; quality-of-life assessment
Intervention type(s): Biological; Procedure
Intervention MeSH terms: Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: quality of life; stage IV colon cancer; recurrent colon cancer; recurrent rectal cancer; stage IV rectal cancer