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

ABSTRACT: Interventions: TAS-102 plus bevacizumab combination therapy (q4w) TAS-102: 35mg/m2 BID on days 1-5 and 8-12 Bevacizumab: 5mg/kg on day1 and 15 Primary outcome(s): Progression-free survival Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2637963 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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

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

Project description: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 Non-randomized

| 2645202 | ecrin-mdr-crc

TAS-CC4 Study

| 2614211 | ecrin-mdr-crc

TAS-102 and Bevacizumab as salvage line chemotherapy for colorectal cancer

Project description:Interventions: TAS-102(35mg/m2) is administered orally twice daily in 1-5days and 15-20 days and Bevacizumab(5mg/kg) is administered by injection in day 1 and day15. 1 cycle is 28days. Primary outcome(s): Progression Free Survival Study Design: Single arm Non-randomized

| 2646936 | ecrin-mdr-crc

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

Project description:Interventions: TAS-102(35mg/m2) is administered orally twice daily in 1-5days and 15-20 days and Bevacizumab(5mg/kg) is administered by injection in day 1 and day15. 1 cycle is 28days. Primary outcome(s): Disease control rate Study Design: Single arm Non-randomized

| 2641267 | ecrin-mdr-crc

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

Project description:Interventions: TAS-102: 35mg/m2 given orally twice a day in a 28-day cycle, 2-week cycle of 5 days treatment followed by a 2-day rest period, and then a 14-day rest period Bevacizumab: 5mg/kg given intravenously in a 2-week cycle Primary outcome(s): progression free survival Study Design: Single arm Non-randomized

| 2637697 | ecrin-mdr-crc

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

| 2637698 | ecrin-mdr-crc

TAS-102 plus Bevacizumab combination as salvage therapy in elderly patients with metastatic colorectal cancer, phase 2 trial

Project description:Interventions: TAS-102: 35mg/m2 given orally twice a day in a 28-day cycle, 2-week cycle of 5 days treatment followed by a 2-day rest period, and then a 14-day rest period Bevacizumab: 5mg/kg given intravenously in a 2-week cycle Primary outcome(s): overall survival Study Design: Single arm Non-randomized

| 2636928 | ecrin-mdr-crc

TAS-102 plus Bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer, phase 2 trial

Project description:Interventions: TAS-102: 35mg/m2 given orally twice a day in a 28-day cycle, 2-week cycle of 5 days treatment followed by a 2-day rest period, and then a 14-day rest period Bevacizumab: 5mg/kg given intravenously in a 2-week cycle Primary outcome(s): relative dose intensity Study Design: Single arm Non-randomized

| 2635519 | ecrin-mdr-crc

Multicenter Phase 1b/2 Trial of TAS-102 with Bevacizumab in Patients with Metastatic Colorectal Cancer (mCRC) who had the progression or intolerant to standard therapies.

Project description:Interventions: 1 cycle is 28days. TAS-102(35mg/m2) is administered orally twice daily in 1-5days and 8-12 days and Bevacizumab(5mg/kg) is administered by injection in day 1 and day15. Primary outcome(s): 4 month progression free survival by central assessment( 4M PFS) Study Design: Single arm Non-randomized

| 2628236 | ecrin-mdr-crc

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