Leucovorin, Fluorouracil, Cetuximab, and Oxaliplatin in Treating Patients With Stage IV Colorectal Cancer and Liver Metastases That Cannot Be Removed by Surgery

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: NCT00544349
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : May 17, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) and giving them together with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving leucovorin together with fluorouracil, cetuximab, and oxaliplatin works in treating patients with stage IV colorectal cancer and liver metastases that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Biological: cetuximab Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Phase 2

Detailed Description:



  • Determine the efficacy of this regimen by the measurement of objective response rate (RECIST criteria).


  • Determine the toxicity of this regimen.
  • Evaluate the duration of tumor response.
  • Determine the duration and rate of tumor control.
  • Determine the rate of secondary resectability of hepatic metastases.
  • Evaluate progression-free survival
  • Determine rate of progression of the tumor.
  • Determine overall survival.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1 hour, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours. Patients also receive oxaliplatin by hepatic arterial infusion over 2 hours. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Effectiveness of the Association of Chemotherapy LV5FU2 Simplified and Cetuximab With Intra-arterial Hepatic Chemotherapy Using Oxaliplatin in Patients With Colorectal Cancer and Nonresectable Hepatic Metastases
Study Start Date : October 2006
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Efficacy: objective tumor response rate (RECIST criteria)

Secondary Outcome Measures :
  1. Toxicity as assessed by NCI CTCAE v3.0
  2. Duration of response
  3. Duration and rate of tumor control
  4. Secondary resectability of hepatic metastases
  5. Progression-free survival
  6. Overall survival
  7. Tumor progression rate

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed primary cancer of the colon or rectum

    • Isolated hepatic metastases
    • Not amenable to curative resection or requirement for complex and or larger (i.e., > 4 liver segments) liver resection
  • Measurable disease (RECIST criteria)
  • Original tumor must be (or have been) removed


Inclusion criteria:

  • WHO performance status 0-1
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Creatinine ≤ 1.5 times normal
  • Bilirubin ≤ 1.5 times upper limit of normal
  • Transaminases ≤ 5 times normal
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

Exclusion criteria:

  • Contraindication or allergy grade 3-4 to any components of the study drugs
  • Peripheral neuropathy
  • Intestinal occlusion or subocclusion or prior inflammatory intestinal disease
  • Severe cardiac disease including any of the following:

    • Symptomatic coronary disease
    • Myocardial infarction in the past 6 months
    • New York Heart Association grade II-IV cardiac insufficiency
    • Severe arrhythmia (even if treated)
  • Active or uncontrolled infection
  • Other concurrent serious disorder
  • Severe uncontrolled medical condition
  • Other malignancy within the past 5 years or concurrently except basal cell skin cancer or carcinoma in situ of the cervix
  • Study impossible due to psychological, geographical, or social reasons
  • Prisoners or patients under guardianship


Exclusion criteria:

  • Prior chemotherapy except adjuvant chemotherapy comprising fluorouracil, leucovorin calcium, capecitabine, oxaliplatin, irinotecan hydrochloride, and/or bevacizumab (completed > 6 months ago if oxaliplatin- or irinotecan-based)
  • Prior epidermal growth factor (EGF), monoclonal antibody inhibiting transduction of EGF receptor (EGFR), or any other treatment targeting the EGFR
  • Other concurrent anticancer immunotherapy, chemotherapy, or hormone therapy
  • Participation in another study in the past 30 days

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): NCT00544349

Hopital Saint Andre
Bordeaux, France, 33075
Centre Regional Francois Baclesse
Caen, France, 14076
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
CHU Pitie-Salpetriere
Paris, France, 75651
Centre Eugene Marquis
Rennes, France, 35062
Hopital Paul Brousse
Villejuif, France, 94804
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
OverallOfficial: David Malka, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT00544349     History of Changes
Other Study ID Numbers: CDR0000564063
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
recurrent colon cancer
stage IV rectal cancer
recurrent rectal cancer
liver metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
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
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents