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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:
Information provided by (Responsible Party):
Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00286130
First received: February 2, 2006
Last updated: April 30, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 2, 2006
Last Updated: April 30, 2012
Health Authority: Austria: Federal Ministry for Health and Women

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
Fluorouracil
Oxaliplatin
Irinotecan
Cetuximab
 Leucovorin
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 June 17, 2013