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Multicenter Phase II Study of XELOX with Bevacizumab in the Late Elderly Patients with Unresectable Advanced/Recurrent Colorectal Cancer

ABSTRACT: Interventions: XELOX+BV regimen (Capecitabine, Oxaliplatin, Bevacizumab) Primary outcome(s): Progression Free Survival Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2618959 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Analysis of pharmacokinetics and pharmacodynamics for capecitabine during new chemotherapy regimen by bevacizumab (Bev) in combination with XELOX in unresectable colorectal cancer

Project description:Interventions: Measurement ofcapecitabin metabolism during XELOX+BV 5-days on/ 2-days off schedule Primary outcome(s): Confirmation for PK/PD analysis of capecitabine Study Design: Single arm Non-randomized

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Gene expression profiling of biopsy and resection samples from the DEBIOC phase 1 trial of oxaliplatin and capecitabine +/- AZD8931 in oesophageal cancer

Project description:The Dual Erb B Inhibition in Oesophago-gastric Cancer (DEBIOC) trial reported an acceptable safety profile for neoadjuvant Oxaliplatin and Capecitabine (Xelox) +/- AZD8931 in oesophageal adenocarcinoma (OAC) but limited efficacy. We evaluated the impact of neoadjuvant Xelox +/-AZD8931 on biological pathways using a unique software-driven solution. Transcriptomic profiles from 25 pre-treatment FFPE OAC biopsies and 17 matched resection specimens, treated with Xelox+AZD8931 (n=16) and Xelox alone (n=9), were analysed using the Almac claraT total mRNA report. Tumour Infiltrating Lymphocytes (TILs) were assessed digitally using QuPath software. Hierarchical clustering identified three molecular subgroups classified by activation of innate immune signalling. The Immune High subgroup was associated with HER2 positivity, increased pathological response and a marked reduction in immune signalling and TILs following neoadjuvant therapy. The Immune Low cluster was pre-dominantly HER2/EGFR negative and EGFR positivity was associated with the Immune Mixed subgroup. Neoadjuvant therapy induced angiogenesis and EMT signalling and a reduction in DNA repair signatures with AZD8931 also promoting an immunosuppressive microenvironment. OAC may be subdivided into three immune-related subgroups which undergo modulation in response to neoadjuvant therapy with marked suppression of the immune microenvironment in HER2 positive/Immune High tumours.

2024-09-01 | E-MTAB-13741 | biostudies-arrayexpress

Phase II trial as new chemotherapy regimen for bevacizumab (Bev) in combination with XELOX in unresectable colorectal cancer.

Project description:Interventions: XELOX+BV 5-days on/ 2-days off Schedule Primary outcome(s): Progression free survival. Study Design: Single arm Non-randomized

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Recurrent breakpoint genes in colorectal cancer

Project description:In this study our aim was to document recurrent DNA copy number aberration associated breakpoints in primary tumors of colorectal cancer patients that ultimately received systemic treatment in the context of metastatic disease. Such data can be used to catalogue copy number aberration associated breakpoints and thereby affected genes. To this end, high quality arrayCGH data set of clinically well annotated colorectal cancer specimens was generated using FFPE tumor samples from patients from two phase III clinical trials, namely CAIRO and CAIRO2. arrayCGH data of colorectal cancers of patients from 2 clinical trials. 108 patients were treated with capecitabine first line, 110 patients were treated with capecitabine and irinotecan first line and 134 patients were treated with capecitabine, oxaliplatin and bevacizumab.

2014-11-14 | E-GEOD-63216 | biostudies-arrayexpress

Evaluation of the reintroducing FOLFOX or XELOX +/- BV in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy.(REACT study)

Project description:Interventions: FOLFOX +/- BV therapy L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 +/- BV:5mg/m2 XELOX +/- BV therapy L-OHP:130mg/m2 Cape:2,000mg/day +/- BV:7.5mg/m2 Primary outcome(s): response rate disease control rate Study Design: Single arm Non-randomized

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Phase 3 Study of Surgery Combined With Neoadjuvant Chemotherapy(XELOX) in Colorectal Cancer With Resectable Liver Metastasis

Project description:This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) .

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A multicenter phase II study of pazopanib in patients with unresectable dermatofibrosarcoma protuberans

Project description:Dermatofibrosarcoma protuberans (DFSP) is a soft-tissue sarcoma characterized by a high risk of local infiltration. The identification of the COL1A1-PDGFB t(17;22) translocation activating the PDGF pathway led to the use of imatinib in unresectable DFSP, with a response rate of 36-80%. Pazopanib is a multitarget tyrosine kinase inhibitor approved for soft tissue sarcomas. We conducted a phase II study of patients with unresectable DFSP to evaluate the efficacy and safety of pazopanib. Patients received 800 mg pazopanib daily. The primary endpoint was the objective response rate defined as the reduction of the largest diameter of the tumor ≥30% at 6 months or at surgery assessed by physical examination. Twenty-three patients, including one pre-treated with imatinib, were enrolled. With a median follow-up of 6.2 months (interquartile range 5.6-7.8 months), 5 patients (22%, 95% CI: 7-22%) had a partial response to pazopanib. The best objective response rate was 30% (95% CI 13-53%) using RECIST. One patient with metastatic DFSP previously treated with imatinib died after 2.4 months. Nine (39%) patients discontinued the treatment due to adverse events. Pharmacodynamics analyses of tumor samples were conducted: the enrichment of EGF and the EGFR-associated gene panel was associated with resistance, suggesting that EGFR-targeted therapies could be a therapeutic option to explore in DFSP.

2020-05-19 | GSE150787 | GEO

XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer

Project description:XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes). Bloodsamples will be collected and frozen and later examined for potential predictive factors

| 2020447 | ecrin-mdr-crc

Prospective cohort study of optimal discontinuation of oxaliplatin in elderly patients treated with XELOX plus bevacizumab

Project description:Interventions: XELOX+BEV Capecitabine:2000mg/m2 d1-14 Oxaliplatin:130mg/m2 d1 Bevacizumab:7.5mg/kg d1 Q3w Discontinuation of oxaliplatin when neurotoxicity develops >=Grade2 Primary outcome(s): Rate of Grade3 neuropathy Study Design: Single arm Non-randomized

| 2631347 | ecrin-mdr-crc

A Study of Bevacizumab Plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer

Project description:The objective is to investigate the efficacy and safety of two-weekly alternative regimen of Bevacizumab plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer.

| 2334327 | ecrin-mdr-crc

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