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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00743678
First received: August 27, 2008
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Colorectal Cancer
Unresectable Liver Metastasis
 Drug: FOLFOX6/cetuximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate (according to RECIST) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Progression-free survival time [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Overall survival timeToxicity profile (according to NCI CTCAE v3) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Correlative analyses between pretreatment EGFR, KRAS mutation and response rate/survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 73
Study Start Date: June 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NEO
NEO : Neoadjuvant therapy with FOLFOX6 plus cetuximab
 Drug: FOLFOX6/cetuximab
Neoadjuvant FOLFOX6/cetuximab

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743678

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

No publications provided

Responsible Party: Young Suk Park M.D.,Ph.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00743678     History of Changes
Other Study ID Numbers: 2008-04-018
Study First Received: August 27, 2008
Last Updated: January 10, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Colorectal Cancer
Unresectable liver metastasis
FOLFOX6
Cetuximab
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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013