FLOX in Combination With Cetuximab in First-line Treatment of Colorectal Cancer

January 13, 2011 updated by: The Nordic Colorectal Cancer Biomodulation Group

5-Fluorouracil/Folinate/Oxaliplatin (Eloxatin) (FLOX Regimen), Given Continuously or Intermittently, in Combination With Cetuximab (Erbitux), in First-line Treatment of Metastatic Colorectal Cancer. A Phase III Multicenter Trial.

The main objective of this trial is to explore the effect of combining an established chemotherapy regimen (FLOX), based on 5-fluorouracil, folinic acid, and oxaliplatin (Eloxatin®), with the EGF receptor antibody cetuximab (Erbitux®) in first-line treatment of metastatic colorectal cancer. The trial will investigate two regimens of FLOX plus cetuximab, in which FLOX is given continuously or intermittently, compared to standard FLOX without cetuximab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

571

Phase

  • Phase 3

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

  • Norway
      • Oslo, Norway, NO-0407
        • The Nordic Colorectal Cancer Biomodulation Group

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

14 years to 70 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 disease
  • If only one metastatic lesion and no S-CEA elevation, histology is mandatory;
  • Availability of tumour sample for EGFR assessment.

General conditions:

  • Age >18 and < 75 years;
  • WHO performance status: life expectancy of more than 3 months;
  • Adequate haematological function
  • Adequate renal and hepatic functions
  • Written informed consent

Exclusion Criteria:

Prior therapy:

  • No prior chemotherapy for advanced/metastatic disease;
  • No adjuvant chemotherapy the last 6 months before inclusion;
  • No previous oxaliplatin;

Prior or current history:

  • No current indication for resection with a curative intent;
  • No evidence of CNS metastasis;
  • No current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
  • No current history of chronic diarrhoea;
  • No peripheral neuropathy;
  • No other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies);
  • No 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:

  • No concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation;
  • No concurrent treatment with any other anti-cancer therapy;

Other:

  • Not pregnant, no breast feeding
  • Fertile patients must use adequate contraceptives
  • Not include patients clearly intending to withdraw from the study if not randomised in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar or geographic reasons.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
FLOX: 5-fluorouracil/folinic acid/oxaliplatin; Nordic Regimen; given continuosly
Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin)
FLOX every 2nd week
Experimental: B
FLOX: 5-fluorouracil/folinic acid/oxaliplatin and cetuximab
Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab
FLOX every 2nd week Cetuximab weekly
Experimental: C
FLOX given intermittently and maintenance cetuximab
Drug: FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab

FLOX every 2nd week for 8 cycles. Stop of FLOX until progression then FLOX is reintroduced.

Cetuximab weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare efficacy, as measured by time to disease progression, of treatment with cetuximab in combination with the FLOX regimen compared to FLOX alone, in first- line treatment of patients with metastatic cororectal cancer
Time Frame: Every 4th cycle
Every 4th cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
To measure response rates, response duration, secondary surgical curative resection frequency, safety profile, overall survival and quality of life in the treatment groups.
Time Frame: Every 2nd week (safety profile)
Every 2nd week (safety profile)

Collaborators and Investigators

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

Sponsor

The Nordic Colorectal Cancer Biomodulation Group

Investigators

  • Principal Investigator: Kjell M. Tveit, MD, PhD, Professor at Ullevål University Hospital, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2005

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

January 14, 2011

Last Update Submitted That Met QC Criteria

January 13, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nordic VII
  • EudraCT no.: 2005-000117-34

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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