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Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

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ClinicalTrials.gov Identifier: NCT00189683
Recruitment Status : Unknown
Verified September 2005 by Association Européenne de Recherche en Oncologie.
Recruitment status was:  Recruiting
First Posted : September 19, 2005
Last Update Posted : September 19, 2005
Sponsor:
Collaborator:
Information provided by:

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
Colorectal Cancer Procedure: Monitoring Procedure: Xeloda Phase 3

Study Design

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

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

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:

  • 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

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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): NCT00189683


Contacts
Contact: Annie Jouhaud + 33 1 43 77 72 10 annie.jouhaud@aero-eu.org

Locations
France
AERO Recruiting
Creteil, France, 94000
Contact: Elizabeth Fabre-Guillevin, MD    + 33 1 43 77 72 10    elizabeth.fabre-guillevin@egp.aphp.fr   
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
More Information

ClinicalTrials.gov Identifier: NCT00189683     History of Changes
Other Study ID Numbers: AERO-MC04
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 19, 2005
Last Verified: September 2005

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
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents