Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency (MESH)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was Recruiting
Information provided by:
Royal Marsden NHS Foundation Trust
First received: July 31, 2009
Last updated: December 3, 2013
Last verified: August 2009
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).
Advanced Colorectal Cancer
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Non-randomised Phase II Trial of Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Disease stabilisation rate; progression free survival; 1 year survival and median overall survival; Quality of Life assessment; toxicity assessment.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952016
|The Royal Marsden NHS Foundation Trust
|Sutton, Surrey, United Kingdom, SM2 5PT |
|Contact: Dr Madeleine Hewish +44 02071535340 email@example.com |
|Principal Investigator: Prof David Cunningham |
Royal Marsden NHS Foundation Trust
No publications provided
||The Royal Marsden NHS Foundation Trust
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 31, 2009
||December 3, 2013
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
Keywords provided by Royal Marsden NHS Foundation Trust:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Abortifacient Agents, Nonsteroidal
Reproductive Control Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors