Conditions: Colorectal Cancer Neoplasm Metastasis
Keywords: Previously untreated metastatic colorectal cancer Metastatic Colorectal Cancer combined therapy biologics therapy antibody chemotherapy EGFR epidermal growth factor receptor
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: no

Brief summary:
This is a Phase II, open label, non-randomized study in subjects with histologically confirmed diagnosis of advanced KRAS wild type adenocarcinoma of the colon or rectum, who have not received prior chemotherapy for metastatic disease.

Detailed description:
The current treatment options for metastatic colon cancer are in need of further improvement. The three-drug combination of oxaliplatin with 5-FU/LV (fluorouracil/leucovorin) in the second-line treatment of metastatic colorectal cancer have shown a significant increase in response rate compared to 5-FU/LV alone. Oxaliplatin has recently been FDA-approved for this indication and is now a standard first-line agent in combination with a fluoropyrimidine. Cetuximab, a chimeric monoclonal antibody against the growth factor receptor, has shown activity with and without irinotecan in subjects with colorectal cancer refractory to irinotecan alone. 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 fluoropyrimidine/oxaliplatin-based regimen in the 1st line setting should be explored. The use of the oral fluoropyrimidine, capecitabine, to replace infusional 5FU has been widely used for improved convenience and possible safety. We have chosen a modified biweekly CapeOx (capecitabine plus oxaliplatin) regimen due to its improved tolerance and response rate with a fixed dose of capecitabine given its widespread practice and ease of use.

Arms:
arm 1: None

Interventions: intervention 1: Cetuximab intervention 2: Oxaliplatin intervention 3: Capecitabine
Intervention descriptions: intervention 1: 500 mg/m2, IV every two weeks intervention 2: 85 mg/m2, IV, q 2 weeks intervention 3: 2500 mg, po bid x 7 days every two weeks

Protocol document: