Capecitabine in combination with Oxaliplatin, Irinotecan and Bevacizumab (COI-B regimen) as First-Line therapy for metastatic colorectal cancer: a Phase II I.T.M.O. study. - COI B

• Conditions: Patients affected by colorectal carcinoma untreated with metastasis; MedDRA version: 9.1Level: LLTClassification code 10025856Term: Malignant neoplasm of colon stage IV

• Registration Number: EUCTR2008-008749-39-IT
• Lead Sponsor: I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-24
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histologically proven diagnosis of colon or rectum carcinoma Presence of metastasis not suitable for surgery Presence of measurable disease with at least one target lesion with a minimum lesion size as per the RECIST criteria Patients must not have previously received systemic treatment for advanced disease. Adjuvant chemotherapy or neo-adjuvant treatment for non-metastatic disease (M0) is allowed if completed at least 6 months prior to initiation of the study treatment. If prior adjuvant therapy was received, patients must not have progressed during therapy or within 6 months of its completation. Age < 70 yrs PS ECOG 0-1-2 (tumor-related performance status deterioration) Patients must sign an informed consent document Male and female patients with reproductive potential must use an approved contraceptive methods.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of inflammatory bowel disease and/or acute/subacute bowel occlusion. Serious non-healing wound or ulcer. Evidence of bleeding diathesis or coagulopathy. Uncontrolled hypertension. Evidence of brain metastasis Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (&#8804; 6 months), myocardial infarction (&#8804; 6 months), unstable angina, NYHA grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objectives Determine the efficacy in terms of : Response rate Safety profile of the COI regimen when administered with bevacizumab Safety profile of bevacizumab when administered after the end of chemotherapy;Secondary Objective: To evaluate : Duration of response Progression Free Survival Time from last bevacizumab dose to progression disease Overall survival;Primary end point(s): Primary Objectives Determine the efficacy in terms of : Response rate Safety profile of the COI regimen when administered with bevacizumab Safety profile of bevacizumab when administered after the end of chemotherapy