Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency — MESH  

Advanced Colorectal Cancer Clinical Trial

Official title: A Non-randomised Phase II Trial of Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency

Status Terminated

Clinical Trial Summary

To assess the efficacy of methotrexate in a genetically selected population of patients with advanced colorectal cancer, who have loss of a particular gene, MSH2. The efficacy of methotrexate will be evaluated by the proportion of cases that have a significant response to treatment (objective response rate).

Clinical Trial Description

The study will involve treating 29 subjects with methotrexate given intravenously. All subjects will receive treatment; there is no control arm or randomisation. The subjects will be known to have deficiency of MSH2, or a mutation (genetic change) in MSH2 that stops it functioning normally. This can either be demonstrated by testing for loss of MSH2 protein in the tumour itself, or by the demonstration of a mutation in the MSH2 gene in the subject's blood. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT00952016
• Study type: Interventional
• Source: Royal Marsden NHS Foundation Trust
• Status: Terminated
• Phase: Phase 2
• Start date: February 2009
• Completion date: September 2014