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Brief Title: Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma
Official Title: Metronomic Chemotherapy With Anti-angiogenic Effect as Maintenance Treatment for Metastatic Colorectal Carcinoma Following Response to FOLFIRI+Bevacizumab: Clinical and Laboratory Studies
Study ID: NCT01668680
Brief Summary: Colorectal cancer patients with metastases (mCRC) at response under expensive chemotherapy which may be toxic +/- exhausting are candidates for an effective and more convenient maintenance treatment. Objectives: 1. To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM) regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab. 2. To discover predictive factors for response to this LDM regimen. Hypothesis: 1. The re-growth of residual metastases can be slowed by the anti-angiogenic effects of LDM chemotherapy. 2. Serial measurements of angiogenic/ inflammatory factors in the plasma and/or evaluation of certain enzymes in the tumor may discover predictive factors of response to LDM chemotherapy in metastatic CRC patients.
Detailed Description: At entry to the research protocol the up-till then administered treatment with Intra Venous FOLFIRI+BEVACIZUMAB will be stopped.Instead, the research oral treatment will be initiated to be taken daily on an ambulatory basis and under once monthly re-evaluation. If and when disease progresses the original FOLFIRI+BEVACIZUMAB treatment will be considered for re-institution.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
HaEmek Medical Center, Afula, , Israel
Name: David Loven, MD
Affiliation: Ha'Emek MC
Role: PRINCIPAL_INVESTIGATOR