FLOX + Cetuximab (Erbitux®) for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor

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: NCT00660582
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : January 21, 2015
Odense University Hospital
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital

Brief Summary:

The Nordic FLOX-regime consists of a combination of bolus 5-FU, leukovorin and oxaliplatin (Eloxatin®). Cetuximab (Erbitux®) is an antibody against the epidermal growth factor receptor (EGFR). The combination of FLOX and weekly Erbitux has been investigated in the Nordic VII study where 571 patients were randomized to FLOX (regime A) or FLOX + Erbitux (regime B or C). Effect-data has not yet been published but the combination is well tolerated, and other studies have shown that Erbitux administered with chemotherapy seem to be more efficient than chemotherapy alone.

The main purpose with this study is to investigate the effect of FLOX and Erbitux given every second week as first line treatment for patients with metastatic colorectal cancer and K-RAS wildtype tumor.

The latest accessible data regarding treatment towards EGFR and K-RAS mutations shows that patients with K-RAS wildtype responds better to treatment than patients with K-RAS mutations.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Cetuximab (Erbitux) Drug: Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FLOX + Cetuximab (Erbitux®): First Line Treatment for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor, A Phase II Study
Study Start Date : April 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

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

Intervention Details:
    Drug: Cetuximab (Erbitux)
    500 mg/m² every second week, intravenous infusion, 8 cycles
    Drug: Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid
    Given in combination day 1 and 2, every second week, 8 cycles

Information from the National Library of Medicine

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

Inclusion Criteria:

Histology and staging disease:

  • Histological proven adenocarcinoma of the colon or rectum
  • At least one measurable metastatic lesion according to RECIST criteria
  • If only one metastatic lesion, histology is mandatory

Mutation level:

  • Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR

General conditions:

  • Age >18 and < 75 years
  • WHO performance status ≤ 2; life expectancy of more than 3 months
  • Adequate haematological function: (Hb ≥ 6.2 μmol/d, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L)
  • Adequate renal and hepatic functions: total bilirubin ≤ 1.5 upper normal limit, creatinine ≤ 1.25 × upper normal limit, ALAT ≤ 3 x upper normal limits, and ≤ 5 x upper normal limits in case of liver metastases
  • Written informed consent prior to randomisation must be obtained and documented according to the local regulatory requirements


  • Fertile patients must use adequate contraceptives

Exclusion Criteria:

Prior therapy:

  • Prior chemotherapy for advanced/metastatic disease
  • Adjuvant chemotherapy must have ended > 6 months before inclusion
  • Prior treatment with Eloxatin
  • Prior treatment with Erbitux or other treatment to EGFR

Prior or current history:

  • Current indication for resection with a curative intent
  • Evidence of CNS metastasis
  • Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis
  • Current history of chronic diarrhea
  • Peripheral neuropathy
  • Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies)
  • Past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix

Concomitant treatments:

  • Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation
  • Concurrent treatment with any other anti-cancer therapy


  • Pregnant or breast feeding women

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): NCT00660582

Department of Oncology, Aalborg University Hospital
Aalborg, Denmark, 9800
Department of Oncology, Herlev University Hospital
Herlev, Denmark, 2630
Department of Oncology, Odense University Hospital
Odense, Denmark, 5000
Department of Oncology, Haukeland University Hospital
Bergen, Norway
Kreftsenteret, Ullevaal University Hospital
Oslo, Norway, 0407
Section of Oncology, Uppsala University Hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Per Pfeiffer
Odense University Hospital
Principal Investigator: Per Pfeiffer, MD Odense University Hospital, Odense, Denmark

Responsible Party: Per Pfeiffer, Professor, Odense University Hospital Identifier: NCT00660582     History of Changes
Other Study ID Numbers: Nordic 7.5
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Per Pfeiffer, Odense University Hospital:
Colorectal cancer
Fluorouracil + folinic acid

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Folic Acid
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Growth Substances