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

January 20, 2015 updated by: Per Pfeiffer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9800
        • Department of Oncology, Aalborg University Hospital
      • Herlev, Denmark, 2630
        • Department of Oncology, Herlev University Hospital
      • Odense, Denmark, 5000
        • Department of Oncology, Odense University Hospital
  • Norway
      • Bergen, Norway
        • Department of Oncology, Haukeland University Hospital
      • Oslo, Norway, 0407
        • Kreftsenteret, Ullevaal University Hospital
  • Sweden
      • Uppsala, Sweden, 751 85
        • Section of Oncology, Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Per Pfeiffer

Collaborators

Odense University Hospital

Investigators

  • Principal Investigator: Per Pfeiffer, MD, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 11, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 20, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nordic 7.5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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