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Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency (MESH)

This study has been terminated.
(Lack of recruitment - only 2 patients recruited.)
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust Identifier:
First received: July 31, 2009
Last updated: October 13, 2016
Last verified: August 2009

July 31, 2009
October 13, 2016
February 2009
September 2014   (final data collection date for primary outcome measure)
Objective response rate, to include complete response and partial response, as defined radiologically using RECIST (Response, Evaluation Criteria in Solid Tumours) on imaging CT scans performed during treatment.
Same as current
Complete list of historical versions of study NCT00952016 on Archive Site
Disease stabilisation rate; progression free survival; 1 year survival and median overall survival; Quality of Life assessment; toxicity assessment.
Same as current
Not Provided
Not Provided
Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency
A Non-randomised Phase II Trial of Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency
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).
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.
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Colorectal Cancer
Drug: Methotrexate
study subjects will receive methotrexate intravenously on day 1 and day 8 of a 3 weekly cycle.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2014
September 2014   (final data collection date for primary outcome measure)

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)
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Not Provided
Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
Not Provided
Not Provided
Royal Marsden NHS Foundation Trust
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP