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Phase II study investigating efficacy and safety of TFTD plus bevacizumab by RAS mutation status in patients with unresectable advanced or recurrent colorectal cancer refractory or intolerant to standard chemotherapy

ABSTRACT: Interventions: TFTD: 35 mg/m. given orally twice daily on days 1-5 and 8-12 in a 28-day cycle Bevacizumab: 5 mg/kg, administered by intravenous infusion for 30 min every 2 weeks Primary outcome(s): Disease control rate (DCR) by RAS mutation status Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2645249 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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PhaseII study investigating efficacy and safety of TFTD plus bevacizumab by RAS mutation status in patients with unresectable advanced or recurrent colorectal cancer refractory or intolerant to standard chemotherapy (JFMC51-1702-C7)

Project description:Interventions: TFTD: 35 mg/m. given orally twice daily on days 1-5 and 8-12 in a 28-day cycle, Bevacizumab: 5 mg/kg, administered by intravenous infusion for 30 min every 2 weeks Primary outcome(s): Disease control rate (DCR) by RAS mutation status Study Design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose

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A Phase 2 study of concurrent combination therapy of TFTD (TAS-102) and bevacizumab in patients of more than 70 years of age with unresectable, advanced/recurrent colorectal cancer (KSCC 1602)

Project description:Interventions: TFTD 35 mg/m2, po, bid at day 1-5 and day 8-12 and bevacizumab 5mg/kg, iv, every 2 weeks are concurrently administered. The administration is continued until the meeting of discontinuation criteria as 1 course of 28 days. Primary outcome(s): Progression-Free Survival Study Design: Single arm Non-randomized

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A Phase 2 study of concurrent combination therapy of TFTD (TAS-102) and bevacizumab in patients of more than 70 years of age with unresectable, advanced/recurrent colorectal cancer (KSCC 1602)

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Microflow LC-MS/MS based proteomics of Escherichia Coli and Fosfomycin Experiment 2

Project description:Thermal proteome profiling of E. coli lysate treated with fosfomycin 0.02 mg/ml. Untargeted proteomics with 35 min gradient.

2022-10-09 | MSV000090499 | MassIVE

A phase II study of TFTD plus Bevacizumab in patients with unresectable advanced colorectal cancer

Project description:Interventions: TFTD: fixed dose Bevacizumab: fixed dose Primary outcome(s): Time to treatment failure Study Design: Single arm Non-randomized

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Modulation of the FOLFIRI-based standard 1st-line therapy with cetuximab, controlled by monitoring the RAS mutation load by liquid biopsy in RAS-mutated mCRC patients

Project description:Interventions: Group 1: FOLFIRI or mFOLFIRI (q14d) + cetuximab (q7d): o Irinotecan 180 mg/m² iv, 30 - 90 min, day 1 o Folinic acid (racemic) 400 mg/m² iv, 120 min, day 1 o [5-FU 400 mg/m² bolus, day 1] o 5-FU 2400 mg/m² iv over 46 h, day 1-2 o Cetuximab initially 400 mg/m² as a 120 min infusion (= 5 mg/min); subsequently 250 mg/m² iv as a 60 min infusion (= 10 mg/min), day 1 + 8 One cycle consists of 14 days Group 2: FOLFIRI (q14d): o Irinotecan 180 mg/m² iv, 30 - 90 min, day 1 o Folinic acid (racemic) 400 mg/m² iv, 120 min, day 1 o Fluorouracil (5-FU) 400 mg/m² bolus, day 1 o 5-FU 2400 mg/m² iv over 46 h, day 1-2 OR modified FOLFIRI (mFOLFIRI) (q14d): o Irinotecan 180 mg/m² iv, 30 - 90 min, day 1 o Folinic acid (racemic) 400 mg/m² iv, 120 min, day 1 o 5-FU 2400 mg/m² iv over 46 h, day 1-2 Primary outcome(s): The primary objective is to evaluate efficacy in terms of progression free survival (PFS) from the date of randomization in the study according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria in experimental and control arms. Study Design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment

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Evaluation of outcome and reason of treatment termination of TFTD for colorectal cancer : A retrospective cohort study

Project description:Primary outcome(s): We compare the difference of the overall survival by each reason (RECIST PD, PD by imaging beyond RECIST PD, Clinical PD , adverse event, others) for termination of TFTD.

| 2642797 | ecrin-mdr-crc

Dicer-microRNA-Myc circuit promotes transcription of hundreds of long noncoding RNAs

Project description:Long noncoding RNAs (lncRNAs) are important regulators of cell fate, and their mis-expression has been implicated in many diseases. While distinct polymerases generate messenger vs. noncoding ribosomal or tRNAs3, little is known about distinct mechanisms controlling lncRNA expression. Here we show that transcription of lncRNAs is quantitatively different from that of messenger RNAs (mRNAs)--as revealed by deficiency of Dicer (Dcr), a key ribonuclease that generates microRNAs (miRNAs). Loss of Dcr in mouse embryonic stem cells (mESCs) led surprisingly to decreased level of the majority of lncRNAs. The canonical Dgcr8-Dcr-miRNA pathway is required for robust lncRNA expression, at the level of transcriptional initiation and elongation of lncRNA genes rather than at the level of their stability. cMyc, an oncogenic transcription factor, whose expression is indirectly regulated by Dcr-miRNA in mESCs, is partly responsible for lncRNA transcription. Loss of cMyc led to a more dramatic decrease of lncRNAs than mRNAs, and cMyc overexpression rescues lncRNA expression in Dcr KO cells. A quantitative metric of “mRNA-lncRNA decoupling” revealed that Dcr and cMyc differentially regulate lncRNAs vs. mRNAs in diverse cell types and in vivo, as evidenced by hundreds of microarray experiments. Thus, Dcr and cMyc may allow numerous lncRNAs to be activated or deactivated as a class, implicating lncRNAs to potential regulatory roles in development and disease states where Dcr and cMyc have been associated with.

2014-06-15 | GSE55338 | GEO

Final efficacy and biomarker analysis of the sorafenib arm of the BATTLE (Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination) trial

Project description:Purpose: To determine the 8-week disease control rate (DCR) of sorafenib monotherapy in patients with advanced non-small-cell lung cancer (NSCLC) in the BATTLE trial. Methods: Patients with pre-treated NSCLC consented to baseline biopsies for pre-specified biomarkers assessment and biomarker discovery. Sorafenib was given at 400 mg orally twice daily until tumor progression or unacceptable toxicity. Outcomes by pre-specified biomarkers were analyzed and a Sorafenib sensitivity signature developed using high-throughput gene expression profiles of NSCLC cell lines and baseline biopsies. Results: 105 patients were eligible and 98 patients were evaluable. Median age was 62 (range 34-81) years, 51% of patients were male, 75% were former/current smokers, and 89% had an ECOG performance status of 0-1. Median prior chemotherapies for stage IV NSCLC were two. Median follow-up was 9.4 (range: 1.3-32.2) months. Overall, 8-week DCR was 58.2%. Patients with EGFR mutations had significantly lower 8-week DCR compared to patients with wild-type tumors (23.1% vs. 64.2%, P=0.0119), and patients with K-RAS mutations had the highest 8-week DCR (67%). Most commonly reported treatment-related adverse events include hand-foot syndrome (59.6%), fatigue (42.3%), rash (40.4%), diarrhea (38.5%), and weight loss (38.5%). Sorafenib sensitivity signature developed in cell lines was associated with an improved outcome. Conclusion: Patients with wild-type EGFR, including those with K-RAS mutation, may benefit from sorafenib as opposed to patients with EGFR mutation. We identify a gene expression signature associated with an improved outcome in patients with wild-type EGFR treated with sorafenib. BATTLE-2 trial is ongoing to validate those results. ClinicalTrials.gov number, NCT00411671.

2014-06-01 | GSE31428 | GEO

Expression profiling of lung cancer cell lines

Project description:Purpose: To determine the 8-week disease control rate (DCR) of sorafenib monotherapy in patients with advanced non-small-cell lung cancer (NSCLC) in the BATTLE trial. Methods: Patients with pre-treated NSCLC, ECOG performance status (PS) 0-2, consented to biopsies to test for biomarker assessment. Sorafenib was given at 400 mg orally twice daily until tumor progression or an unacceptable toxicity. Tumor evaluations were performed at baseline and every 8 weeks. Correlations of outcomes by biomarker groups were analyzed. Results: 105 patients were eligible and 98 patients were evaluable. Median age was 62 (range 34-81) years, 51% of patients were male, 75% were former/current smokers, and 89% had an ECOG PS of 0-1. Median prior chemotherapies for stage IV NSCLC were two. Median follow-up was 9.4 (range: 1.3-32.2) months. Eight-week DCRs by histology were 59.1%, 57.1%, and 55.6% for adenocarcinomas, squamous cell carcinomas and other histologies respectively. Patients with tumors harboring EGFR mutations had significantly lower 8-week DCR compared to patients with wild-type tumors (23.1% vs. 64.2%, P=0.0119), and patients with tumors harboring K-RAS mutations had the highest 8-week DCR (67%). Most commonly reported treatment-related adverse events include hand-foot syndrome (59.6%), fatigue (42.3%), rash (40.4%), diarrhea (38.5%), and weight loss (38.5%). Conclusion: 8-week DCR was better in patients treated with sorafenib who had EGFR wild-type tumors (including those with K-RAS mutations) when compared to those who had EGFR mutations. Additional analyses are warranted to further explore the biology of these tumors and related patient outcomes with sorafenib treatment. ClinicalTrials.gov number, NCT00411671.

2012-06-18 | GSE32036 | GEO

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