Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Association Européenne de Recherche en Oncologie.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Association Européenne de Recherche en Oncologie
ClinicalTrials.gov Identifier:
NCT00189683
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention Phase
Colorectal Cancer
Procedure: Monitoring
Procedure: Xeloda
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Association Européenne de Recherche en Oncologie:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00189683     History of Changes
Other Study ID Numbers: AERO-MC04
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014