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TAS-CC4 Study

ABSTRACT: Interventions: TAS-102: 35mg/m2 given orally twice daily on days 1-5 and 15-19 in a 28-day cycle. Bevacizumab: 5mg/kg given intravenously in a 2-week cycle Primary outcome(s): progression free survival Study Design: single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose

DISEASE(S): Colorectal Cancer

PROVIDER: 2614211 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial

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TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial

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Phase 2 trial of TAS-102 plus bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on oxaliplatin, irinotecan and fluoropyrimidine

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A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy

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TAS-102, Irinotecan, and Bevacizumab in Pre-treated Metastatic Colorectal Cancer (TABAsCO), A Phase II Clinical Trial. ClinicalTrials.gov NCT04109924

Project description:Background: The efficacy of FOLFIRI plus an antiangiogenesis biologic agent as 2nd line therapy for metastatic colorectal adenocarcinoma is limited. TAS-102 is a novel oral antimetabolite with a distinct mechanism of action from fluoropyrimidines. We evaluated the antitumor efficacy of TAS-102, irinotecan and bevacizumab in patients with pre-treated, advanced colorectal adenocarcinoma in a multicenter, phase II, single-arm study. Methods: Patients with advanced colorectal adenocarcinoma who had progressed after oxaliplatin and fluoropyrimidine and were eligible for treatment with bevacizumab were treated with irinotecan, bevacizumab, and TAS-102 in 28-day cycles. The primary endpoint was progression-free survival (PFS). Results: We enrolled 35 evaluable patients. The study was positive. The median PFS was 7.9 (90% CI 6.2-11.8) months (vs. 6 months in historical control, p=0.018). The median overall survival was 16.5 (90% CI 9.8-17.5) months. Sixty-seven percent of patients experienced grade 3 or higher treatment-related adverse events. The most common toxicities were hematological (neutropenia) and gastrointestinal (diarrhea, nausea, and vomiting). Conclusions: Irinotecan, TAS-102 and bevacizumab is an active 2nd line therapy for patients with metastatic colorectal adenocarcinoma. Neutropenia is common and can affect dose density/intensity mandating use of G-CSF. A randomized study versus standard of care therapy is warranted.

2024-08-26 | GSE275628 | GEO

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