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Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

Sponsor
Association Européenne de Recherche en Oncologie (Other)
Overall Status
Unknown status
CT.gov ID
NCT00189683
Collaborator
Roche Pharma AG (Industry)
1
Location

Study Details

Study Description

Brief Summary

To compare maintenance chemotherapy with Xeloda to control after best response with first line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival. A total of 300 patients will be included.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Monitoring
  • Procedure: Xeloda
 Phase 3

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with metastatic colorectal cancer (confirmed histologically) with objective response or stabilization after at least 6 cycles of first line chemotherapy (treatment of choice is selected freely by the investigator according to the recommendations and consensus in force),

    • The interval between completion of first line chemotherapy and randomization should not exceed 4 weeks

    • Age>18 years

    • ECOG status 0 to 2

    • Biological criteria prior to any chemotherapy:

    Neutrophils>1.5 109 g/l, platelets>100 109/l, haemoglobin>10 g/dl, Creatininaemia<150 mol/l, bilirubinaemia<2x normal level

    • Signed informed consent

    • Life expectancy > 3 months

    Exclusion Criteria:

    • Metastatic colorectal cancer treated with more than one modality of first line chemotherapy (including oral fluoropyrimidines)

    • Tumour progression after first line chemotherapy or before randomization

    • Other tumour pathology

    • Symptomatic cerebral metastases

    • Any severe uncontrolled disease in addition to colorectal cancer (in particular decompensated cardiac failure (LVEF<50%) or coronary insufficiency)

    • Lack of integrity of the upper GI tract: malabsorption syndrome or major surgery of the stomach or the small intestine

    • Severe renal impairment (creatinine clearance < 30 ml/min)

    • Severe psychiatric disorder (other than controlled depressive syndrome)

    • Patient participating in another experiment

    • Pregnant women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AERO Creteil France 94000

    Sponsors and Collaborators

    • Association Européenne de Recherche en Oncologie
    • Roche Pharma AG

    Investigators

    • Principal Investigator: Elizabeth Fabre-Guillevin, MD, AERO
    • Principal Investigator: Eric Van Cutsem, MD, BGDO
    • Principal Investigator: Marc Polus, MD, BGDO

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00189683
    Other Study ID Numbers:
    • AERO-MC04
    First Posted:
    Sep 19, 2005
    Last Update Posted:
    Sep 19, 2005
    Last Verified:
    Sep 1, 2005
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Capecitabine

    Study Results

    No Results Posted as of Sep 19, 2005