Status:
TERMINATED
Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Advanced Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 def...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00952016
Start Date
February 1 2009
End Date
September 1 2014
Last Update
October 14 2016
Active Locations (1)
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1
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT