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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00286130
First Posted: February 3, 2006
Last Update Posted: May 1, 2012
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.
Information provided by (Responsible Party):
Central European Cooperative Oncology Group
  Purpose

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


Condition Intervention Phase
Metastatic Colorectal Cancer Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan Drug: FOLFOX 6 Drug: FOLFIRI Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Central European Cooperative Oncology Group:

Primary Outcome Measures:
  • the percentage of patients surviving without disease progression in each arm at 9 months

Secondary Outcome Measures:
  • PFS rates at 3,6,12 months
  • Response rates
  • Overall survival (OS) in each arm
  • Safety

Enrollment: 150
Study Start Date: July 2005
Study Completion Date: October 2007
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00286130


  Show 27 Study Locations
Sponsors and Collaborators
Central European Cooperative Oncology Group
Investigators
Principal Investigator: Werner Scheithauer, MD Dep. of Internal Medicine I, Medical University of Vienna
  More Information

Responsible Party: Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00286130     History of Changes
Other Study ID Numbers: CECOG/Core 1.2.001
EUDRACT number 2004-002391-42
First Submitted: February 2, 2006
First Posted: February 3, 2006
Last Update Posted: May 1, 2012
Last Verified: April 2012

Keywords provided by Central European Cooperative Oncology Group:
metastatic colorectal cancer
FOLFOX 6
FOLFIRI

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
Oxaliplatin
Irinotecan
Cetuximab
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action