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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00743678
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : June 14, 2013
Information provided by (Responsible Party):
Young Suk Park, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Unresectable Liver Metastasis Drug: FOLFOX6/cetuximab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
Study Start Date : June 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: NEO
NEO : Neoadjuvant therapy with FOLFOX6 plus cetuximab
Drug: FOLFOX6/cetuximab
Neoadjuvant FOLFOX6/cetuximab

Primary Outcome Measures :
  1. To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Response rate (according to RECIST) [ Time Frame: 24 months ]
  2. Progression-free survival time [ Time Frame: 24 months ]
  3. Overall survival timeToxicity profile (according to NCI CTCAE v3) [ Time Frame: 24 months ]
  4. Correlative analyses between pretreatment EGFR, KRAS mutation and response rate/survival [ Time Frame: 24 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00743678

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Young Suk Park, M.D.,Ph.D. Samsung Medical Center, Seoul, Korea

Responsible Party: Young Suk Park, Professor, Samsung Medical Center Identifier: NCT00743678     History of Changes
Other Study ID Numbers: 2008-04-018
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: June 14, 2013
Last Verified: June 2013

Keywords provided by Young Suk Park, Samsung Medical Center:
Colorectal Cancer
Unresectable liver metastasis
Neoadjuvant therapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Antineoplastic Agents