Neoadjuvant FOLFOX6 + Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis

Colorectal Cancer Clinical Trial

Official title: A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis

Status Completed

Clinical Trial Summary

An innovative therapeutic strategy to increase the complete resection rate is of utmost importance in order to enhance survival in colorectal cancer patients with unresectable liver-only metastasis. Therefore, the investigators propose a prospective study of neoadjuvant chemotherapy using FOLFOX6 plus cetuximab to convert initially unresectable liver metastasis to potentially resectable disease.

Clinical Trial Description

We will include the patients with unresectable liver-only metastatic disease independent of EGFR status. The results of this study will show the resection rate with neoadjuvant treatment in patients with colorectal cancer with liver-only metastasis.

Restaging including CT after #3, #6, #9, and #12 cycles of FOLFOX + Cetuximab

If any time, patients have PD, Off-study SD, Continue study treatment until resectable, up to #12 cycles, PD, or toxicities PR or more, If resectable, go to surgery : resection of liver metastasis and primary tumor, if present If unresectable, continue until resectable, up to #12 cycles, PD, or toxicities

Overall, a total of 12 cycles of treatment including neoadjuvant therapy will be given either before, after or without surgery.

CT scans will be performed every 3 cycles during the first 12 cycles (6 months). After that, CT scans will be performed every 2 months for another 6 months, then every 3 months for 6 months, then once a year or earlier if a PD is probable.

AEs will be evaluated once every cycle and during the CT evaluation visit.. Patients that can only undergo R1 resection or are unable to get surgery at all, will be evaluated regularly until PD.

Radiofrequency ablation (RFA) may be allowed as a palliative local therapy in patients that are suitable for it. RFA is not considered equal to a resection. ;

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis
• Unresectable Liver Metastasis

• NCT number: NCT00743678
• Study type: Interventional
• Source: Samsung Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: June 2008
• Completion date: June 2012