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A Randomised Phase II Trial of Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency

Phase 2
18 Years
Open (Enrolling)
Advanced Colorectal Cancer

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Trial Information

A Randomised Phase II Trial of Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency

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.

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

- 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

February 2009

Completion Date:

July 2014

Related Keywords:

  • Advanced Colorectal Cancer
  • colorectal cancer
  • MSH2
  • metastatic
  • Colorectal Neoplasms