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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743678
• Other study ID #: 2008-04-018
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2008
• Last updated: June 13, 2013
• Start date: June 2008
• Est. completion date: June 2012

Study information

• Verified date: June 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Intervention

Drug:
• FOLFOX6/cetuximab
Neoadjuvant FOLFOX6/cetuximab

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis		18 months	Yes
Secondary	Response rate (according to RECIST)		24 months	Yes
Secondary	Progression-free survival time		24 months	Yes
Secondary	Overall survival timeToxicity profile (according to NCI CTCAE v3)		24 months	Yes
Secondary	Correlative analyses between pretreatment EGFR, KRAS mutation and response rate/survival		24 months	Yes