Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer

April 30, 2012 updated by: Central European Cooperative Oncology Group

A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer

In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety.

The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC.

EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively.

Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.

Study Type

Interventional

Enrollment (Actual)

150

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

  • Austria
      • Wien, Austria, 1090
        • Univ. Klinik für Innere Medizin I
    • Steiermark
      • Leoben, Steiermark, Austria, 8700
        • LKH Leoben, Abt. für Innere Medizin
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Institute of Oncology
  • Bulgaria
      • Sofia, Bulgaria, 1754
        • SBALO National Oncology Center
      • Sofia, Bulgaria, 1504
        • University Hospital "Queen Joanna"
  • Croatia
      • Zagreb, Croatia
        • University Hospital Rebro
      • Zagreb, Croatia
        • University Hospital For Tumors
  • Cyprus
      • Nikosia, Cyprus
        • Bank of Cyprus Oncology Center
  • Czech Republic
      • Brno, Czech Republic, 62500
        • Univ. Hospital Brno, Dept. Of Clinical Oncology
      • Prague, Czech Republic, 12808
        • Charles University Prague, Dep. of Oncology
  • Hungary
      • Budapest, Hungary, 1135
        • National Medical Center
      • Szomathely, Hungary, 39700
        • Markusovsy Hospital
      • Veszprem, Hungary, 8200
        • Csolnoky Ferenc County Hospital
  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Center
      • Tel Aviv, Israel
        • Souraski medical center
  • Portugal
      • Amadora, Portugal, 2720
        • Hospital Amadora Sintra, Servico de Oncologia
      • Beja, Portugal, 78000
        • Hospital de Beja
      • Faro, Portugal, 8000-386
        • Hospital Distrital de Faro
      • Porto, Portugal, 4000-377
        • Hospital Geral de Sto. António
      • Viseu, Portugal
        • Hospital San Teotóno -
  • Romania
      • Bucuresti, Romania
        • Institutul Oncologic Bucuresti
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic Cluj
  • Slovakia
      • Bratislava, Slovakia, 83310
        • National Cancer Institute
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology
  • Turkey
      • Ankara, Turkey
        • Gazi University Medical Faculty
      • Ankara, Turkey
        • Ankara Hacettepe University, Oncology Unit
      • Izmir, Turkey
        • 9 Eyul University Medical Faculty, Dep of Oncology

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
  • Metastatic colorectal carcinoma not suitable for curative-intent resection
  • Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment
  • Presence of at least one lesion measurable unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area)
  • ECOG performance status of < 2 at study entry

Exclusion Criteria:

  • Brain metastasis (known or suspected)
  • Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months
  • Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry
  • Cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
  • Any investigational agent(s) within 4 weeks prior to entry
  • Previous exposure to EGFR-pathway targeting therapy

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: FOLFOX 6

FOLFOX 6:

  • Oxaliplatin 100 mg/m² d1 concurrent with
  • Leucovorin 400 mg/m², followed by
  • Bolus 5FU 400 mg/m² , followed by
  • Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
Drug: FOLFOX 6

FOLFOX 6:

  • Oxaliplatin 100 mg/m² d1 concurrent with
  • Leucovorin 400 mg/m², followed by
  • Bolus 5FU 400 mg/m² , followed by
  • Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
Active Comparator: FOLFIRI

FOLFIRI:

  • Irinotecan 180 mg/m² day 1 concurrent with
  • Leucovorin 400 mg/m² followed by
  • Bolus 5FU 400 mg/m², followed by
  • Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
Drug: FOLFIRI

FOLFIRI:

  • Irinotecan 180 mg/m² day 1 concurrent with
  • Leucovorin 400 mg/m² followed by
  • Bolus 5FU 400 mg/m², followed by
  • Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
the percentage of patients surviving without disease progression in each arm at 9 months

Secondary Outcome Measures

Outcome Measure
Safety
Response rates
PFS rates at 3,6,12 months
Overall survival (OS) in each arm

Collaborators and Investigators

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

Sponsor

Central European Cooperative Oncology Group

Investigators

  • Principal Investigator: Werner Scheithauer, MD, Dep. of Internal Medicine I, Medical University of Vienna

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

July 1, 2005

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 2, 2006

First Submitted That Met QC Criteria

February 2, 2006

First Posted (Estimate)

February 3, 2006

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 30, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CECOG/Core 1.2.001
  • EUDRACT number 2004-002391-42

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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