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A prospective study comparing targeted anticancer drug + irinotecan and targeted anticancer drug + 5-Fluorouracil / Leucovorin as maintenance treatment after primary induction chemotherapy for metastatic colorectal cancer

ABSTRACT: Interventions: Drug : This randomized phase 2 clinical trial aims to evaluate the effect of the Bevacizumab/Cetuximab+Irinotecan group compared to the Bevacizumab/Cetuximab+5-fluorouracil/Leucovorin group as maintenance therapy. Administer according to the recommended dosage regimen or the standard of the local institution Experomental group Bevacizumab or Cetuximab + Irinotecan, control group Bevacizumab or Cetuximab + 5 fluorouracil therapy every 2 weeks Recommended dose for Experomental group : Bevacizumab 5mg kg IV Day1, Cetuximab 500mg/m2 IV Day1 , Irinotecan 180mg/m2 IV Day1 Recommended dose of control group: Bevacizumab 5mg kg IV Day1, Cetuximab 500mg/m2 IV Day1,Leucovorin 400mg/m2 IV Day1, 5-fluorouracil 400mg/m2 IV bolus Day1 , 5-fluorouracil 2,400mg/m2 IV Day1-2 Primary outcome(s): Percentage of patients with progression-free status after secondary chemotherapy at one year from random assignment 1yr-PFS2 rate Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Open, Allocation : RCT

DISEASE(S): Neoplasms

PROVIDER: 74818 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:KRAS mutation is a negative predictive factor for treatment with anti-epidermal growth factor receptor (EGFR) antibodies in metastatic colorectal cancer (mCRC). Novel predictive markers are required to further improve the selection of patients for this treatment. Here, we assessed the influence of modification of KRAS by gene copy number aberration (CNA) and microRNAs (miRNAs) in correlation to clinical outcome in mCRC patients treated with cetuximab in combination with chemotherapy and bevacizumab. Formalin-fixed paraffin-embedded primary tumour tissue was used from 34 mCRC patients in a phase III trial, who were selected based upon their good (n=17) or poor (n=17) progression-free survival (PFS) upon treatment with cetuximab in combination with capecitabine, oxaliplatin, and bevacizumab. Gene copy number at the KRAS locus was assessed using high resolution genome-wide array CGH and the expression levels of 17 miRNAs targeting KRAS were determined by real-time PCR. Good response was associated with 12p12.1 copy number loss, even in patients with a KRAS mutation, while copy number gain in wild-type KRAS patients was correlated with a poor response. In KRAS mutated tumours increased miR-200b and decreased miR-143 expression were associated with a good response. In wild-type KRAS patients, miRNA expression did not predict response in a multivariate model. Thus, assessment of KRAS CNA and miRNAs targeting KRAS might further optimize the selection of patients eligible for anti-EGFR therapy. Copy number detection was performed using NimbleScan and Nexus software Formalin-fixed paraffin-embedded primary tumour tissue was used from 34 metastisized colorectal cancer patients in a phase III trial (CKTO 2005-02; ClinTrials.gov NCT00208546) of the Dutch Colorectal Cancer Group (DCCG), who were selected based upon their good (n=17) or poor (n=17) progression-free survival (PFS) upon treatment with cetuximab in combination with capecitabine, oxaliplatin, and bevacizumab.

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A prospective study comparing targeted anticancer drug + irinotecan and targeted anticancer drug + 5-Fluorouracil / Leucovorin as maintenance treatment after primary induction chemotherapy for metastatic colorectal cancer

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