A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer
The current treatment options for metastatic colon cancer are in need of further
improvement. The three-drug combination of oxaliplatin with 5-FU/LV for the first-line
treatment of metastatic colorectal cancer has shown a significant increase in response rate
compared to IFL (irinotecan and bolus 5-FU plus leucovorin ) and IROX (irinotecan plus
oxaliplatin. Cetuximab has shown activity with and without irinotecan in subjects with
colorectal cancer refractory to irinotecan alone.30,31 Cetuximab has also been shown to be
safe and effective when administered with infusional 5-FU/folinic acid plus irinotecan.
These results suggest that the addition of cetuximab to a 5-FU/LV/oxaliplatin-based regimen
(FOLFOX) used in the 1st line setting may lead to the development of more treatment options
for subjects with advanced colorectal cancer.
This is a Phase II, open label, non-randomized study in patients with histologically or
pathologically confirmed diagnosis of stage IIIB/IV, EGFR+ adenocarcinoma of the colon or
rectum who have not received prior chemotherapy for their metastatic disease.
Patients will receive a modified FOLFOX 6 regimen (5-FU, leucovorin, and oxaliplatin) every
2 weeks in combination with cetuximab given weekly.
Patients will be evaluated for response and progression-free survival. Overall survival
will also be evaluated, as well as the safety profile of the regimen.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the response rate, progression-free survival, and overall safety profile of a modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with metastatic colorectal cancer.
Ralph Boccia, MD
United States: Food and Drug Administration
|Veeda Oncology||Houston, Texas 77042|