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Spots Global Cancer Trial Database for Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency

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Trial Identification

Brief Title: Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency

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

Study ID: NCT00952016

Interventions

Methotrexate

Study Description

Brief 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).

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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