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

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00660582
First received: April 11, 2008
Last updated: December 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Metastatic Colorectal Cancer
Drug: Cetuximab (Erbitux)
Drug: Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid
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: FLOX + Cetuximab (Erbitux®): First Line Treatment for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor, A Phase II Study

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Enrollment: 152
Study Start Date: April 2008
Study Completion Date: February 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Other:

  • 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

Other:

  • Pregnant or breast feeding women
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660582

Locations
Denmark
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
Norway
Department of Oncology, Haukeland University Hospital
Bergen, Norway
Kreftsenteret, Ullevaal University Hospital
Oslo, Norway, 0407
Sweden
Section of Oncology, Uppsala University Hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Per Pfeiffer, MD Odense University Hospital, Odense, Denmark
  More Information

No publications provided

Responsible Party: Per Pfeiffer, MD, Department of Oncology, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00660582     History of Changes
Other Study ID Numbers: Nordic 7.5
Study First Received: April 11, 2008
Last Updated: December 18, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:
Erbitux
Colorectal cancer
Oxaliplatin
Flox
Fluorouracil + folinic acid
K-RAS

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Cetuximab
Leucovorin
Folic Acid
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 20, 2014