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Pulsatile High-dose Sunitinib Versus TAS-102 in Patients With Metastatic Colorectal Carcinoma (mCRC)

ABSTRACT: The purpose of this study is to compare progression free survival rates of metastasized colorectal cancer patients refractory or intolerant to systemic therapy with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)); randomized for treatment with TAS-102 (standard-arm) or High Dose Intermittent Sunitinib (700 mg once every 2 weeks). The investigators hypothesis is that treatment with the experimental arm (sunitinib) will provide an improvement in progression free in this patient group.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms,Metastasis

PROVIDER: 2302467 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A randomized phase II study of pulsatile high-dose sunitinib versus TAS-102 in patients with metastatic colorectal carcinoma (mCRC).

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MicroRNA expression in peripheral blood predicts poor and prolonged response to sunitinib.

Project description:Peripheral blood samples were taken before initiation of therapy and 2 weeks later from patients with advanced renal cell carcinoma treated with sunitinib in first line. MicroRNA expression in peripheral blood was assessed using microarrays and several models predicting poor response and prolonged response to sunitinib were constructed and evaluated. Peripheral blood samples obtained before initiation of therapy with sunitinib and 14 days later were used to assess expression values of miRNAs.

2013-02-11 | E-GEOD-32099 | biostudies-arrayexpress

Differentially expressed genes analysis between dihydroberberine, sunitinib and dihydroberberine plus sunitinib.

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A trial testing TAS-102 therapy versus an alternative high-dose, intermittent scheduling for sunitinib in patients with metastatic colorectal carcinoma.

Project description:Primary objectives: The primary objective of this study is to improve progression free survival (PFS), of patients with metastatic colorectal carcinoma (mCRC) treated with high-dose sunitinib once every 2 weeks to 5 months, compared to the reported 2 months for TAS-102 monotherapy Primary endpoints: The primary objective of this study is to improve PFS of patients with stage IV colorectal carcinoma, who progressed on (or are intolerant to) 5-FU, oxaliplatin, irinotecan, anti-VEGF (and/or anti-EGFR) containing therapy, treated with high-dose sunitinib (once every 2 weeks) to 5 months, compared to 2 months for patients treated with TAS-102 monotherapy. Progression free survival is defined as the time from randomization to the date of the first documented tumor progression as determined by the investigator using RECIST 1.1 criteria or death due to any cause. PFS between patients included in the two different study arms will be compared.

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Differentially expressed genes analysis between dihydroberberine, sunitinib and dihydroberberine plus sunitinib.

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miRNA array of clear cell renal cell carcinoma from patients treated with sunitinib

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Sunitinib treatment exacerbates intratumoral heterogeneity in metastatic renal cancer

Project description:The aim of this study was to investigate the effect of VEGF targeted therapy (sunitinib) on intratumoral heterogeneity (ITH) in metastatic clear cell renal cancer (mRCC).

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MicroRNA expression in peripheral blood predicts poor and prolonged response to sunitinib.

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Expression data from breast cancer tumors treated with a single window of the antiangiogenic agent Sunitinib

Project description:We have witnessed the rise and fall of antiangiogenic therapy in breast cancer (BC). Nevertheless, clinical remissions were observed in patients and we were interested in studying the activity of antiangiogenic drugs in BC. Inefficacy of sunitinib was observed in mouse models of metastatic BC, where evidence of enhanced metastasis was reported, and lack of efficacy of sunitinib-docetaxel combination was recently reported in a phase III clinical trial. Our aim was to understand the mechanisms and predictors of response to sunitinib in BC in a cohort of patients with untreated locally advanced or operable BC treated with an upfront window of single agent sunitinib, followed by the combination of sunitinib and docetaxel. We have used microarray profiing to monitor the transcriptional changes associated with three distinct stages of treatment: at diagnosis and prior to any treatment (t1), after an upfront window of single agent sunitinib (t2) and after the combined treatment of sunitinib and docetaxel (t3). In addtion, this microarray data also allowed us to observe the transcriptional changes associated with primary resistance to angiogenic therapy in 4 of 12 patients likely mediated by an adaptive transcriptional response to hypoxia in these resistant tumors. In BC patients this is the first demonstration of primary resistance to antiangiogenic therapy.

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Sunitinib treatment exacerbates intratumoral heterogeneity in metastatic renal cancer (CGH)

Project description:The aim of this study was to investigate the effect of VEGF targeted therapy (sunitinib) on intratumoral heterogeneity (ITH) in metastatic clear cell renal cancer (mRCC). To explore ITH in detail, multiple tumor samples were taken from the primary renal tumors of mRCC patients who were sunitinib treated (n=23) or untreated (n=23). ITH of pathological grade, DNA (using array-based comparative genomic hybridisation), RNA (Illumina Beadarray) and protein (reverse phase protein array) were evaluated. Tumor grade heterogeneity was greater in treated compared to untreated tumors (P=0.002). Unsupervised and supervised analysis, for renal cancer driver, hypoxia and stromal gene signatures, was then performed. In untreated patient tumor samples, significant ITH occurred in chromosomal aberrations, RNA and protein expression, with clustering of DNA and RNA correlating for individual patients. In unsupervised analysis sunitinib therapy was not associated with increased ITH in DNA or RNA. However there was an increase in ITH for the driver mutation and hypoxia gene signatures (DNA and RNA) as well as increasing variability of protein expression with treatment (p<0.05). Despite this variability, significant chromosomal and RNA changes to targets of sunitinib, such as VHL, PBRM1 and CAIX, occurred in the treated samples. Together these findings suggest that sunitinib treatment has significant effects on the expression and ITH of key tumor and treatment specific genes. The results do not support the hypothesis that resistant clones are selected and predominate after initiation of targeted therapy; instead it appears that an initial clonal diversification occurs, supporting the hypothesis of polyclonal drug resistance. 128 samples from patients with clear cell renal cell carcinoma, including biological replicates of nephrectomy samples. Source of samples includes both biopsy and nephrectomy. DNA extracted from FFPE and fresh frozen tissue samples.

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