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Phase l and Phase ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type

ABSTRACT: Interventions: S-1 +oxaliplatin (SOX) + cetuximab Cetuximab: loding dose 400 mg/m2, 250 mg/m2/week L-OHP: 75-130 mg/m2 tri-weekly S-1: 80 mg/m2 (80-120 mg/day) Primary outcome(s): Phase I: Maximum Tolerated Dose, Recommended Dose Phase II: Response Rate Study Design: Single arm Non-randomized

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2622442 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A randomized Phase II study comparing SOX+B-mab with SOX+C-mab in patients with previously untreated recurrent advanced colorectal cancer with KRAS wild type.

Project description:Interventions: A group (SOX+B-mab) TS-1 administered for 14 days followed by 7 days rest according to body surface area. L-OHP is administered intravenously in 130 mg/m2 at day 1. B-mab is administered intravenously in 7.5 mg/kg by tri-weekly. B group (SOX+C-mab) TS-1 administered for 14 days followed by 7 days rest according to body surface area. L-OHP is administered intravenously in 130 mg/m2 at day 1. C-mab is administered intravenously in 400 mg/m2 on day 1, then 250 mg/m2 weekly thereafter. Or C-mab is administered intravenously in 500 mg/m2 by bi-weekly. Primary outcome(s): Response rate Study Design: Parallel Randomized

| 2622133 | ecrin-mdr-crc

Research on biomarkers in cetuximab containing combination therapies for patients with KRAS wild-type metastatic colorectal cancer

Project description:Interventions: cetuximab loading dose 400mg/m2, 250mg/m2/week L-OHP 85mg/m2/biweekly levofololinate 200mg/m2/biweekly 5-FU bolus 400 mg/m2/biweekly 5-FU continuous 2,400 mgm2/biweekly / cetuximab loding dose 400 mg/m2, 250 mg/m2/week L-OHP 75-130 mg/m2/tri-weekly S-1 80-120 mg/day, day1-14 Primary outcome(s): Correlation between the reported biomarkers (EGFR expression, ligand expression to EGFR, BRAF, PI3K, and PTEN expression) or new ones (DNA microarray, analysis of microRNA expression, and DNA SNP analysis) and the response to cetuximab containing combination therapies Study Design: Parallel Randomized

| 2626017 | ecrin-mdr-crc

Multicenter Phese II Study of SOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral S-1 plus Bevacizumab Maintenance Therapy in Advanced Colorectal CancerC

Project description:Interventions: (1)Initial therapy : SOX+bevacizumab therapy Bev : 7.5 mg/kg (90 min) L-OHP : 130 mg/m2 (120 min) S-1 : 80 - 120 mg/day (Day1-15) (2)Maintenance therapy : S-1+bevacizumab therapy Bev : 7.5 mg/kg (90 min) S-1 : 80 - 120 mg/day (Day1-15) (3)Reintroduced therapy : SOX+bevacizumab therapy Primary outcome(s): DDC ; Duration of disease control) Study Design: Single arm Non-randomized

| 2627046 | ecrin-mdr-crc

Caveolin-1 and Sox-2 are Predictive Biomarkers of Cetuximab Response in Head and Neck Cancer

Project description:Expression analysis (RNA-seq) and RPPA data (see publication) of head and neck cancer patient-derived xenographs (PDXs) revealed Sox-2 and Cav-1 expression to be biomarker determinants of head and neck cancer patient tumor response to cetuximab (EGFR inhibitor) treatment.

2021-10-12 | GSE183881 | GEO

Randomized phase II study of adding steroid for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein (APOLLO)

Project description:Interventions: XELOX Oxaliplatin 130mg/m2 day1 Capecitabine 2,000mg/m2 day1-14 every 3 weeks SOX Oxaliplatin 130mg/m2 day1 S-1 80-120mg/m2 day1-14 every 3 weeks Oxaliplatin is combined with dexamethasone (2 mg). XELOX Oxaliplatin 130mg/m2 day1 Capecitabine 2,000mg/m2 day1-14 every 3 weeks SOX Oxaliplatin 130mg/m2 day1 S-1 80-120mg/m2 day1-14 every 3 weeks Primary outcome(s): The incidence of venous pain:Grade>=2 Study Design: Parallel Randomized

| 2619736 | ecrin-mdr-crc

The randomized phaseII study of SOX and SIR sequential therapy as TS-1 based regimens in Advanced Colorectal Cancer; WSTAR trial

Project description:Interventions: 1st line chemotheraypy: SOX+Bmab Bmab: 7.5mg/kg every 3weeks L-OHP: 130mg/m2 every 3weeks TS-1: 80-120mg/day 14days on, 7days off 21st 1 course. 2nd line chemotheraypy: SIR+Bmab Bmab: 7.5mg/kg every 3weeks CPT-11: 150mg/m2 every 3weeks TS-1: 80-120mg/day 14days on, 7days off 21st 1 course. 2nd line chemotherapy: choose either (did not use by) 1)SIR+Bmab Bmab: 7.5mg/kg every 3 weeks CPT-11: 150mg/m2 every 3weeks TS-1: 80-120mg/day 14days on, 7 days off 21st 1 course. 2) SIR+Cmab Cmab: 250mg/m2 every week CPT-11: 150mg/m2 every 3 weeks TS-1: 80-120mg/day 14days on, 7days off 21st 1 course. 3)SIR+Pmab Pmab: 6mg/kg every 2 weeks CPT-11: 150mg/m2 every 3 weeks TS-1: 80-120mg/day 14days on, 7days off 21st 1 course 4)SIR CPT-11: 150mg/m2 every 3 weeks TS-1: 80-120mg/day 14days on, 7 days off 21st 1 course. 5)SOX+Bmab Bmab: 7.5mg/kg every 3 weeks L-OHP: 130mg/m2 every 3 weeks TS-1: 80-120mg/day 14days on, 7 days off 21st 1 course. 6)SOX+Cmab Cmab: 250mg/m2 every 2 weeks L-OHP: 130mg/m2 every 3 weeks TS-1: 80-120mg/day 14days on, 7days off 21st 1 course. 7)SOX+Pmab Pmab: 6mg/kg every 2 weeks L-OHP: 130mg/m2 every 3 weeks TS-1: 80-120mg/day 14 days on, 7days off 21st 1 course 8)SOX L-OHP: 130mg/m2 every 3 weeks TS-1: 80-120mg/day 14 days on, 7days off 21st 1 course Primary outcome(s): Overall survival:OS Study Design: Parallel Randomized

| 2623112 | ecrin-mdr-crc

Phase I Clinical Trial of ES-285

Project description:Phase I Safety, Pharmacokinetic and Pharmacogenomic Trial of ES-285, a Novel Marine Cytotoxic Agent Administered as an Infusion over 24 h Every 21 Days in Patients with Solid Tumors Purpose: A dose-escalation, phase I study evaluated the safety, pharmacokinetics, pharmacogenomics and efficacy of ES-285, a novel agent isolated from a marine mollusc, in adult cancer patients. Experimental design: Patients received a 24-hour i.v. infusion of ES-285 once every 3 weeks until disease progression or unacceptable toxicity. The starting dose was 4mg/m2. Dose escalation proceeded according to the worst toxicity observed in the previous cohort. Results: 28 patients were treated with 72 courses of ES-285 across 8 dose levels. No doselimiting toxicities (DLTs) were seen between 4mg/m2 and 128mg/m2. Two out of 4 patients treated at 256mg/m2 had dose-limiting reversible grade 3 transaminitis; one patient at 256mg/m2 also had transient grade 3 central neurotoxicity. One of 3 patients subsequently treated at 200mg/m2 died following drug-related central neurotoxicity. Pharmacokinetic studies indicated dose-proportionality with high volume of distribution (median Vss at 256mg/m2 was 2389L, range 1615-4051L) and long elimination half life (median t1/2 at 256mg/m2 was 29h, range 21-32h). The 3 patients with DLT had the highest drug exposure. Pharmacogenomic studies of paired surrogate tissue samples identified changes in gene expression following treatment that correlated with increasing dose. Pre-treatment 59- and 49-gene sets were identified in blood and skin respectively, that may predict DLT. Disease stabilisation for 6 to 18 weeks was recorded in 9 patients. Conclusion: Using this schedule, 128 mg/m2 was considered safe and feasible. At this dose, pharmacologically relevant concentrations of drug were safely achieved with pharmacogenomic studies indicating changes in the expression of genes of potential biological relevance. Keywords: dose response

2009-04-01 | GSE12062 | GEO

A phase 1b study of the Akt-inhibitor MK-2206 in combination with weekly paclitaxel and trastuzumab in patients with advanced HER2-overexpressing solid tumor malignancies

Project description:16 patients with HER2+ tumors were enrolled (12 breast, 3 gastric, 1 esophageal). 27 samples (12 primary + 15 metastatic) from the 16 unique patients were assayed on Agilent 60K expression microarrays, and association between expression and response data were evaluated to identify potential biomarker of MK2206 response We conducted a phase 1b study of MK-2206 in combination with weekly paclitaxel 80 mg/m2 and trastuzumab 2 mg/kg in patients with HER2+ malignancies. Dose escalation was performed using a modified toxicity probability interval method. Molecular profiling of archived tissue samples and limited PK analyses were performed.

2016-07-31 | E-GEOD-75087 | biostudies-arrayexpress

Panarthropod Sox genes

Project description:Embryonic expression patterns of panarthropod Sox genes

| PRJEB22589 | ENA

Randomized Phase II study of Bevacizumab with SOX versus Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11

Project description:Interventions: SOX+Bevacizumab Bevacizumab 7.5mg/kg/triweekly L-OHP 130 mg/m2/triweekly TS-1 80,100,120 mg/twice/day 1-14, following one week off XELOX+Bevacizumab Bevacizumab 7.5mg/kg/triweekly L-OHP 130 mg/m2/triweekly Capecitabine 2400-4200 mg/twice/day 1-14, following one week off Primary outcome(s): Progression-free survival (PFS) Study Design: Parallel Randomized

| 2622332 | ecrin-mdr-crc

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