NCT00952016

Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Methotrexate	study subjects will receive methotrexate intravenously on day 1 and day 8 of a 3 weekly cycle.

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2009-08-04
• Last updated: 2016-10-14

Locations

1 site across 1 country: United Kingdom