The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Compare overall survival in subjects with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-FU, and LV (FOLFOX4) and cetuximab with FOLFOX4 alone.
Time frame: Every six weeks
Compare the response rates between the two treatment arms.
Time frame: Every six weeks
Compare progression-free survival between the two treatment arms.
Time frame: Every six weeks
Duration of response within each treatment arm.
Time frame: Every six weeks
Time to response within each treatment arm.
Time frame: Every six weeks
Compare the safety profiles between the two treatment arms.
Time frame: Every six weeks
Compare the quality of life (QOL)between the two treatment arms.
Time frame: Every six weeks
Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms.
Time frame: Every six weeks
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400 mg/m2 IV
600 mg/m2 IV
250 mg/m2 IV
ImClone Investigational Site
Little Rock, Arkansas, United States
ImClone Investigational Site
Springdale, Arkansas, United States
ImClone Investigational Site
Fountain Valley, California, United States
ImClone Investigational Site
Gilroy, California, United States
ImClone Investigational Site
Greenbrae, California, United States
ImClone Investigational Site
Orange, California, United States
ImClone Investigational Site
Pomona, California, United States
ImClone Investigational Site
San Diego, California, United States
ImClone Investigational Site
Vista, California, United States
ImClone Investigational Site
Hartford, Connecticut, United States
...and 29 more locations