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A phase I/II study of Cetuximab combined with irinotecan and S-1 as first line therapy in metastatic colorectal cancer patients with KRAS wild type

ABSTRACT: Interventions: Cetuximab; bi-weekly administration 500mg/m2. Irinitecan is administered as an intravenous infusion at a dose of 120mg/m2 on day 1 and 15. And TS-1 is orally administered on days 1-14 of a 28-day cycle. Administration dose of TS-1 is based BSA : BSA<1.25m2, 40mg twice daily; 1.25-1.5m2, 50mg twice daily; >1.5m2, 60mg twice daily. Primary outcome(s): Phase I study To evaluate feasibility Phase II study Response rate Study Design: Single arm Non-randomized

DISEASE(S): Advanced Colorectal Cancer

PROVIDER: 2619853 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A phase II study of Panitumumab combined with Irinotecan and S-1 as second line therapy in metastatic colorectal cancer patients with KRAS wild type

Project description:Interventions: Panitumumab;bi-weekly administration 6mg/kg. Irinitecan is administered as an intravenous infusion at a dose of 120mg/m2 on day 1 and 15. And TS-1 is orally administered on days 1-14 of a 28-day cycle. Administration dose of TS-1 is based BSA : BSA<1.25m2, 40mg twice daily; 1.25-1.5m2, 50mg twice daily; >1.5m2, 60mg twice daily. Primary outcome(s): Response rate Study Design: Single arm Non-randomized

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A phase I/II study of combination therapy with S-1/ CPT-11 plus Panitumumab as second line therapy in metastatic colorectal cancer patients with KRAS wild type

Project description:Interventions: Panitumumab;tri-weekly administration 9mg/kg. and CPT-11 is administered as an intravenous infusion at a dose of 150mg/m2(or 125 mg/m2)on day 1 and TS-1 is orally administered on days 1-14 of a 21-day cycle. Administration dose of TS-1 is based BSA : BSA<1.25m2, 40mg twice daily; 1.25-1.5m2, 50mg twice daily; >1.5m2, 60mg twice daily. Primary outcome(s): phase1 recommend dose of 1st cycle phase2 response rate Study Design: Single arm Non-randomized

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S-1 and CPT-11 plus ramucirumab (IRIS+Rmab) as second-line chemotherapy for patients with oxaliplatin-refractory metastatic colorectal cancer: A multicenter phase II study in Japan (N-DOCC-F-C-1701)

Project description:Interventions: Treatment by IRIS+Rmab Ramucirumab at a dose of 10mg/kg was administered as a 120-min infusion and irinotecan at a dose of 150mg/m2 by adjustment by UGT1A1 was administered as a 90-min infusion every 3 weeks. The dose of S-1 was determined according to the patient’s body surface area (BSA). Specifically, the drug was administered orally twice daily for 14 consecutive days at a dose that did not exceed 40 mg/m2 based on BSA as follows-BSA<1.25m2, 40 mg; BSA 1.25-1.5 m2, 50mg twice daily; and BSA >1.5 m2, 60 mg by adjustment of Ccr. Premedication with a 5-HT3 antagonist combined with dexamethasone (+/-) an NK-1 antagonist was recommended in patients before the administration of irinotecan. This treatment was administered until disease progression, unacceptable toxicity, withdrawal of consent, or the physician’s decision to terminate treatment. Primary outcome(s): progrssion free survival (PFS) Study Design: Single arm Non-randomized

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Multicenter Phase II trial of Irinotecan plus S-1 with cetuximab (IRIS/Cet) in patients with EGFR positive and KRAS wild type of advanced/metastatic colorectal cancer

Project description:Interventions: Irinotecan plus S-1 with cetuximab combination therapy Cetuximab 400mg/m2 day1 and then 250mg/m2 day 8,15,22 weekly until PD, or Cetuximab 500mg/m2 day 1, 15, 29 biweekly until PD Irinotecan 100 mg/m2 day1,15, 30 biweekly until PD S-1 S-1 80mg [BSA<1.25m2] or 100mg [1.25m2<BSA<1.5m2] or 120mg [1.5m2<BSA]/body/day, day 1-14, q4weeks Primary outcome(s): Response rate Study Design: Single arm Non-randomized

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Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)

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Transcription profiling of mouse jejunum detached peyers patch from mice orally administered lactoperoxidase (LPO) to study influence of bovine LPO on the digestive tract.

Project description:Lactoperoxidase (LPO) is a component of milk and other external secretions. Recently, we found antiinflammatory effect of orally administered LPO in mouse model of influenza virus-induced pneumonia. In order to study influence of bovine LPO on the digestive tract as its possible target organ, we performed comprehensive gene expression analysis of the mouse small intestine using GeneChip microarray to compare the effect of LPO with that of water or bovine serum albumin (BSA). We observed that 3 h after single ingestion of LPO the levels of 78 gene expression are upregulated and those of 9 gene expressions are downregulated. Within most changed genes, 5 upregulated and 1 downregulated genes such as FK506 binding protein 5 (FKBP5) and serum/glucocorticoid regulated kinase (SGK) are known to be transcriptionally modulated by glucocorticoid. This result suggests that ingested LPO modulates gene expressions in the small intestine in a glucocorticoid-like manner and this activity may link to its systemic antiinflammatory effects. Experiment Overall Design: Mice were orally administered 200 microL of water (n=3), bovine serum albumin (BSA, 2.5 g/kg body weight, n=3), or bovine lactoperoxidase (LPO, 2.5 g/kg body weight, n=3). Three hours after administration, comprehensive gene expressions of jejunum detached payer's patch were analysed for comparison of LPO administration with water or BSA administration.

2007-11-13 | E-GEOD-5562 | biostudies-arrayexpress

Gene expression profiling using RNA-Seq data of MMTV-Wnt1 tumor tissue from mice treated with E7386

Project description:We conducted an RNA-Seq analysis using total RNA extracted from MMTV-Wnt1 tumor tissues resected from mice orally administered E7386 at 25 or 50 mg/kg twice daily, or vehicle, for 3 days (Day 4) or 7 days (Day 8) and examined the differentially expressed gene levels compared with vehicle at days 4 and 8.

2020-12-21 | GSE158713 | GEO

Data independent acquisition mass spectrometry (DIA-MS) analysis of FFPE rectal cancer samples offers in depth proteomics characterization of response to neoadjuvant chemoradiotherapy

Project description:A total of 97 LARC patients treated at the Institute for Oncology and Radiology of Serbia in the period of 2018-2019 were included in the study. Patients were treated with long-course chemoradiotherapy (CRT): Radiotherapy (RT) was delivered with a total dose of 50.4 Gy in 28 fractions; concomitant chemotherapy (5-FU, 350 mg/m2 daily) and Leucovorin (25 mg/m2 daily) was administered during the first and the fifth week of RT. Patients were evaluated in week 6-8 after treatment completion with pelvic MRI scan and rigid proctoscopy. Pathohistological response after surgery was assessed according to tumor regression grading (TRG) categories by Mandard. Twenty biopsy samples taken at diagnosis were used for proteomic analysis, 9 responders (R, TRG 1-2), and 11 non-responders (NR, TRG 3-5), in order to achieve the maximum range of different molecular features potentially associated with response.

2023-11-21 | PXD040451 | Pride

A Study Comparing Capecitabine Capsule 500 mg (IntasPharmaceuticals Ltd., India) To The Reference Listed Drug XelodaÂ(Capecitabine 500 mg; Roche Pharmaceuticals) In Patients Of BreastCancer Or Colorectal Cancer Under Fed Condition

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