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

NCT ID: NCT00743678

Last Updated: 2013-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2012-06-30

Brief 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.

Detailed 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.

Conditions

Colorectal Cancer; Unresectable Liver Metastasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NEO

NEO : Neoadjuvant therapy with FOLFOX6 plus cetuximab

Group Type: EXPERIMENTAL

FOLFOX6/cetuximab

Intervention Type: DRUG

Neoadjuvant FOLFOX6/cetuximab

Interventions

FOLFOX6/cetuximab

Neoadjuvant FOLFOX6/cetuximab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically proven colorectal cancer with metastatic lesion(s) in the liver that is (are) unresectable
• Age ≥ 18
• ECOG performance 0 - 1
• Adequate organ function ((hepatic transaminases ≤ 5x upper limit of normal, bilirubin < 2.0 x upper limit of normal, and creatinine ≤ 1.5x upper limit of normal, platelet > 100,000/ul, absolute neutrophil count ≥ 1,500/ul)
• At least one measurable lesion by RECIST criteria
• Written informed consent

Exclusion Criteria

• Resectable liver metastasis
• Extrahepatic metastases, regardless of their resectability
• Chronic active hepatitis or cirrhosis
• Prior therapy for metastatic disease
• Pregnant or lactating women
• Uncontrolled medical illnesses including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months
• Previous adjuvant FOLFOX chemotherapy
• Prior adjuvant chemotherapy, if administered within 6 months before study entry
• Known hypersensitivity reaction to any of the components of study treatment
• Prior agents directed against EGFR
• Prior allergic reaction (known sensitivity) to chimerized or murine monoclonal antibody therapy
• Known alcohol or drug abuse
• Participation in another clinical study within the 30 days before registration
• Peripheral neuropathy > grade 1
• Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin of pre-invasive carcinoma of the cervix.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Young Suk Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young Suk Park, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Seoul, Korea

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2008-04-018

Identifier Type: -

Identifier Source: org_study_id