Trial record 1 of 1 for:    royal marsden AND colorectal cancer AND methotrexate
Previous Study | Return to List | Next Study

Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency (MESH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00952016
Recruitment Status : Terminated (Lack of recruitment - only 2 patients recruited.)
First Posted : August 4, 2009
Last Update Posted : October 14, 2016
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

July 31, 2009
August 4, 2009
October 14, 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
Intervention Model: Single Group Assignment
Masking: None (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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
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