Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Monitoring; Procedure: Xeloda

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Annie Jouhaud; Phone Number: + 33 1 43 77 72 10; Email: annie.jouhaud@aero-eu.org

Study Locations

• France
  • Creteil, France, 94000
    • Recruiting
    • AERO
    • Contact: Elizabeth Fabre-Guillevin, MD; Phone Number: + 33 1 43 77 72 10; Email: elizabeth.fabre-guillevin@egp.aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Collaborators and Investigators

• Sponsor: Association Européenne de Recherche en Oncologie
• Collaborators: 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 record dates

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): September 19, 2005
• Last Update Submitted That Met QC Criteria: September 12, 2005
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: AERO-MC04