Patients affected by colorectal carcinoma untreated with metastasis MedDRA version: 9.1 Level: LLT Classification code 10025856 Term: Malignant neoplasm of colon stage IV
Conditions
Sponsors
I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 (≤ 6 months), myocardial infarction (≤ 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed