A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title: A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer

Status Completed

Clinical Trial Summary

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.

Primary Study Endpoint:

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.

Secondary Study Endpoint(s):

To assess overall survival of patients with metastatic colorectal cancer who receive first-line therapy with a modified FOLFOX 6 + cetuximab regimen.

Clinical Trial 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 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. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT00251485
• Study type: Interventional
• Source: Veeda Oncology
• Status: Completed
• Phase: Phase 2
• Start date: March 2004
• Completion date: June 2005