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

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ClinicalTrials.gov Identifier: NCT00286130
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : May 1, 2012
Sponsor:
Information provided by (Responsible Party):
Central European Cooperative Oncology Group

Tracking Information
First Submitted Date  ICMJE February 2, 2006
First Posted Date  ICMJE February 3, 2006
Last Update Posted Date May 1, 2012
Study Start Date  ICMJE July 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2006)
the percentage of patients surviving without disease progression in each arm at 9 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2006)
  • PFS rates at 3,6,12 months
  • Response rates
  • Overall survival (OS) in each arm
  • Safety
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer
Official Title  ICMJE 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
Brief Summary

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

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • 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:
  • 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
Study Arms  ICMJE
  • 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:
    Interventions:
    • Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
    • Drug: FOLFOX 6
  • 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
    Interventions:
    • Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
    • Drug: FOLFIRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2006)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Bosnia and Herzegovina,   Bulgaria,   Croatia,   Cyprus,   Czech Republic,   Hungary,   Israel,   Portugal,   Romania,   Slovakia,   Slovenia,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00286130
Other Study ID Numbers  ICMJE CECOG/Core 1.2.001
EUDRACT number 2004-002391-42
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Central European Cooperative Oncology Group
Study Sponsor  ICMJE Central European Cooperative Oncology Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Werner Scheithauer, MD Dep. of Internal Medicine I, Medical University of Vienna
PRS Account Central European Cooperative Oncology Group
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP