Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency

• Status: Terminated
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Marsden NHS Foundation Trust
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Confirmed diagnosis of metastatic or locally recurrent colorectal carcinoma

• Aged 18 years or older

• Paraffin embedded histological material available for analysis

• Either confirmed loss of expression of MSH2 on immunohistochemistry IHC or confirmed mutation in MSH2 on gene sequencing

• Life expectancy of > 3 months

Exclusion Criteria:

• Previous treatment with methotrexate, either for malignant or non-malignant disease, except when methotrexate was given at low dose with other drugs to modify their effects

• Concomitant uncontrolled medical conditions

• Concomitant metastatic malignancy apart from non-melanotic skin cancers and carcinoma in situ of the uterine cervix in the last 10 years

• Any contraindication to treatment with methotrexate (as this will affect safety)