A Phase II Study of TAS-102, Irinotecan and Bevacizumab in Pre-treated Metastatic Colorectal Cancer (TABAsCO)
This phase II trial studies how well TAS-102, irinotecan, and bevacizumab work in treating patients with pre-treated colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving TAS-102, irinotecan, and bevacizumab may work better in treating patients with colorectal cancer compared to traditional chemotherapy and bevacizumab.
Determine the median progression free survival (PFS) benefit of FOLFIRI naïve patients treated with TAS-102 + irinotecan + bevacizumab as compared to historic control groups treated with FOLFIRI + bevacizumab. Estimate the objective response rate (ORR), median overall survival (OS), and adverse event (AE) profile
Avastin (Bevacizumab); Bevacizumab (); CPT-11 (irinotecan); Camptosar (irinotecan); TAS 102 (); irinotecan ()
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