Colorectal Cancer
Conditions
Brief summary
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.
Interventions
BIOLOGICALcetuximab
400 mg/m2 IV
DRUGoxaliplatin
85 mg/m2 IV
DRUGleucovorin
200 mg/m2 IV
DRUG5-fluorouracil
400 mg/m2 IV
Sponsors
Bristol-Myers Squibb
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented colorectal cancer which is EGFR-positive and is metastatic. * Prior irinotecan, alone or in combination, as first-line treatment of metastatic disease.
Exclusion criteria
* A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy. * Known dihydropyrimidine dehydrogenase (DPD) deficiency. * Known metastases in the central nervous system. * Symptomatic sensory or peripheral neuropathy. * More than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer. * Prior oxaliplatin therapy. * Prior cetuximab or other therapy which targets the EGF pathway. * Prior chimerized or murine monoclonal antibody therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Every six weeks |
Secondary
| Measure | Time frame |
|---|---|
| Compare progression-free survival between the two treatment arms. | Every six weeks |
| Duration of response within each treatment arm. | Every six weeks |
| Time to response within each treatment arm. | Every six weeks |
| Compare the response rates between the two treatment arms. | Every six weeks |
| Compare the quality of life (QOL)between the two treatment arms. | Every six weeks |
| Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms. | Every six weeks |
| Compare the safety profiles between the two treatment arms. | Every six weeks |
Countries
United States
Outcome results
None listed