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:
Royal Marsden NHS Foundation Trust
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00952016
First received: July 31, 2009
Last updated: August 6, 2009
Last verified: August 2009
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Colorectal Cancer |
Drug: Methotrexate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomised Phase II Trial of Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency |
Resource links provided by NLM:
Further study details as provided by Royal Marsden NHS Foundation Trust:
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: | 29 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Methotrexate
study subjects will receive methotrexate intravenously on day 1 and day 8 of a 3 weekly cycle.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952016
Contacts
| Contact: Prof David Cunningham | +44 02086613156 | david.cunningham@rmh.nhs.uk |
| Contact: Dr Madeleine Hewish | +44 02071535332 | madeleine.hewish@icr.ac.uk |
Locations
| United Kingdom | |
| The Royal Marsden NHS Foundation Trust | Recruiting |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| Contact: Dr Madeleine Hewish +44 02071535340 madeleine.hewish@icr.ac.uk | |
| Principal Investigator: Prof David Cunningham | |
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
More Information
No publications provided
| Responsible Party: | The Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00952016 History of Changes |
| Other Study ID Numbers: | CCR3107 |
| Study First Received: | July 31, 2009 |
| Last Updated: | August 6, 2009 |
| Health Authority: | 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:
|
colorectal cancer MSH2 metastatic |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013