Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency (MESH)
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| ClinicalTrials.gov Identifier: NCT00952016 |
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Recruitment Status
:
Terminated
(Lack of recruitment - only 2 patients recruited.)
First Posted
: August 4, 2009
Last Update Posted
: October 14, 2016
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Sponsor:
Royal Marsden NHS Foundation Trust
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Colorectal Cancer | Drug: Methotrexate | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Non-randomised Phase II Trial of Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency |
| Study Start Date : | February 2009 |
| Actual Primary Completion Date : | September 2014 |
| Actual Study Completion Date : | September 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Colorectal Cancer
Drug Information available for:
Methotrexate
U.S. FDA Resources
Intervention Details:
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Drug: Methotrexate
study subjects will receive methotrexate intravenously on day 1 and day 8 of a 3 weekly cycle.
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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952016
Locations
| United Kingdom | |
| The Royal Marsden NHS Foundation Trust | |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
| Responsible Party: | Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00952016 History of Changes |
| Other Study ID Numbers: |
CCR3107 |
| First Posted: | August 4, 2009 Key Record Dates |
| Last Update Posted: | October 14, 2016 |
| Last Verified: | August 2009 |
Keywords provided by Royal Marsden NHS Foundation Trust:
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colorectal cancer MSH2 metastatic |
Additional relevant MeSH terms:
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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 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 |