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

Samsung Medical Center

Status and phase

Completed

Phase 2

Conditions

Unresectable Liver Metastasis

Colorectal Cancer

Treatments

Drug: FOLFOX6/cetuximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00743678

2008-04-018

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.