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Phase II study of Irinotecan, TS-1 and Bevacizumab as second-line treatment in patients with advanced colorectal cancer (KMOG 0708)

ABSTRACT: Interventions: TS-1+CPT-11+Bevacizumab Primary outcome(s): Response Rate Study Design: Single arm Non-randomized

DISEASE(S): Advanced Colorectal Cancer

PROVIDER: 2617282 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase II study of combination chemotherapy with TS-1/irinotecan and bevacizumab as second-line therapy in patient with K-RAS mutation-type metastatic colorectal cancer

Project description:Interventions: TS-1+CPT-11+Bevacizumab TS-1 : 80,100,120mg/twice/day1-14,following two weeks off CPT-11 : 100mg/m2/biweekly Bevacizumab : 5mg/kg/biweekly Primary outcome(s): Response Rate Study Design: Single arm Non-randomized

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A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer

Project description:Interventions: arm A-1:mFOLFOX6+Bevacizumab Bevacizumab 5mg/kg/bi-week L-OHP 85mg/m2/bi-week l-LV 200mg/m2/bi-week 5-FU/bolus 400mg/m2/bi-week 5-FU/infusional 2,400mg/m2/bi-week arm A-2: CapeOX+Bevacizumab Bevacizumab 7.5mg/kg/tri-week L-OHP 130mg/m2/tri-week Capecitabine 1200-2100mg/twice/day(day 1-15) arm B-1:TS-1/CPT-11+Bevacizumab(SIRB) Bevacizumab 7.5mg/kg/tri-week CPT-11 150mg/m2/tri-week S-1 40-60mg/twice/day(day1-15)/tri-week arm B-2:TS-1/CPT-11+Bevacizumab(IRIS/BV) Bevacizumab 5mg/kg/(day1and15)/4-weeks CPT-11 100mg/m2/(day1and15)/4-weeks S-1 40-60mg/twice/day(day1-15)/4weeks Primary outcome(s): Progression free survival(PFS) Study Design: Parallel Randomized

| 2623247 | ecrin-mdr-crc

Phase1study of a combination of CPT-11 and TS-1 and bevacizumab in patients with metastatic colon cancer

Project description:Interventions: We use three drugs (CPT-11, TS-1, bevacizumab) for this trial. The treatment schedule of CPT-11 and bevacizumab are administrated on day 1 and day 15, and of TS-1 is administrated between day1 and day 21. The dosage of CPT-11 are 80-110/m2, and of TS-1 are 80-120mg (the dosage are calculated by body surface area), and of bevacizumab are 5 or 7mg/kg. Primary outcome(s): safety Study Design: Single arm Non-randomized

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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

Phase I/II study of triweekly administration regimen of irinotecan and TS-1 in patients with advanced colorectal cancer

Project description:Interventions: Treatment : TS-1+CPT-11 Primary outcome(s): 1) Phase I To determine the recommended dose 2) Phase II Response Rate Study Design: Single arm Non-randomized

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Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer

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Phase II study of TS-1+Irinotecan+Bevacizumab as second-line treatment in patients with metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy

Project description:Interventions: TS-1+Irinotecan+Bevacizumab therapy Bevacizumab 7.5mg/m2/tri-weekly Irinotecan 150mg/m2/tri-weekly TS-1 80-120mg/day, for 14 days followed by 1 week rest Primary outcome(s): 6-Month Progression Free Survival Rate Study Design: Single arm Non-randomized

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Randomized phase II study of mFOLFOX6 versus TS-1/CPT-11 in patients with advanced/recurrent colorectal cancer

Project description:Interventions: Group A:mFOLFOX6 Day 1 day 2 day 14 L-OHP 2HR l-LV 200mg/m2 5-FU 2,400mg/m2 civ 2HR 46HR ------------- | 5-FU 400mg/m2 iv Rapid Group B:TS-1/CPT-11 CPT-11 80 mg/m2CPT-11 80 mg/m2 1.5 hours 1.5 hours TS-1 40-60 mg/m2 | | | | Day 1 day 15 day 21 day 35 One course takes 35 days (5 weeks). Primary outcome(s): Response Rate(RECIST) Study Design: Parallel Randomized

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Phase II Study of FOLFIRI Plus Bevacizumab (AVASIRI) in Patients as Second Line Chemotherapy of Unresectable Colorectal Cancer

Project description:Interventions: 5-FU, CPT-11, Bevacizumab Primary outcome(s): Assessment of overall response rate (ORR; complete response [CR] + partial response [PR]). Study Design: Single arm Non-randomized

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Sequencing in transcriptomes in Ovarian cancer cell line SKOV3 and bevacizumab-treated SKOV3

Project description:To investigate the possible mechanism of bevacizumab resistance in ovarian cancer ,we examined the changes in gene expression of SKOV3 before and after bevacizumab intervention. Results provide insight into molecular mechanisms of acquired resistance to bevacizumab in ovarian cancer.

2023-12-31 | GSE165419 | GEO

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