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

I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY0 个研究点开始时间: 2009年3月24日最近更新: 2014年8月5日

适应症

试验速览

暂无简介。

•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

•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.

发起方

I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY