Trial record 1 of 1 for:    royal marsden AND colorectal cancer AND methotrexate
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Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency (MESH)

This study is currently recruiting participants.
Verified August 2009 by Royal Marsden NHS Foundation Trust
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00952016
First received: July 31, 2009
Last updated: December 3, 2013
Last verified: August 2009

July 31, 2009
December 3, 2013
February 2009
July 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 ClinicalTrials.gov 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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
29
July 2014
July 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)
Both
18 Years and older
No
Contact: Prof David Cunningham +44 02086613156 david.cunningham@rmh.nhs.uk
Contact: Dr Madeleine Hewish +44 02071535332 madeleine.hewish@icr.ac.uk
United Kingdom
 
NCT00952016
CCR3107
Yes
The 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