- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00952016
Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency (MESH)
October 13, 2016 updated by: Royal Marsden NHS Foundation Trust
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).
Study Overview
Detailed Description
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
Enrollment (Actual)
2
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Surrey
-
Sutton, Surrey, United Kingdom, SM2 5PT
- The Royal Marsden NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
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.
|
Secondary Outcome Measures
Outcome Measure |
---|
Disease stabilisation rate; progression free survival; 1 year survival and median overall survival; Quality of Life assessment; toxicity assessment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (ACTUAL)
September 1, 2014
Study Completion (ACTUAL)
September 1, 2014
Study Registration Dates
First Submitted
July 31, 2009
First Submitted That Met QC Criteria
August 3, 2009
First Posted (ESTIMATE)
August 4, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
October 14, 2016
Last Update Submitted That Met QC Criteria
October 13, 2016
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- CCR3107
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Colorectal Cancer
-
Zhejiang UniversityRecruitingAdvanced Colorectal Cancer | Advanced Hepatocellular Carcinoma | Advanced Gastric Cancer | Advanced Pancreatic CancerChina
-
Array Biopharma, now a wholly owned subsidiary...CompletedMetastatic Colorectal Cancer | Advanced Solid Tumors | Advanced or Metastatic Biliary CancerUnited States
-
University Health Network, TorontoRecruitingAdvanced Breast Cancer | Advanced Colorectal Cancer | Cancer RehabilitationCanada
-
Haihe Biopharma Co., Ltd.UnknownAdvanced Solid Tumor | Advanced/Metastatic Colorectal CancerChina
-
University of ChicagoVerastem, Inc.RecruitingColorectal Cancer | Colorectal Cancer Metastatic | Colorectal Adenocarcinoma | Advanced Colorectal Carcinoma | Advanced Colorectal AdenocarcinomaUnited States
-
Sun Yat-sen UniversityActive, not recruitingDMMR Colorectal Cancer | MSI-H Colorectal Cancer | Locally Advanced Colorectal CancerChina
-
Holy Stone Healthcare Co., LtdCompletedAdvanced or Metastatic Solid Tumors | Advanced or Metastatic Colorectal Cancer (mCRC)United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingMetastatic Colorectal Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Metastatic Microsatellite Stable Colorectal Carcinoma | Advanced Microsatellite Stable Colorectal Carcinoma | Advanced Colorectal AdenocarcinomaUnited States
-
AVEO Pharmaceuticals, Inc.CompletedAdvanced Solid Tumors | Locally Advanced or Metastatic Breast or Colorectal CancerUnited States
-
Mirati Therapeutics Inc.Active, not recruitingMetastatic Colorectal Cancer | Advanced Colorectal CancerUnited States, Denmark, Finland, Italy, Spain, Belgium, Romania, Taiwan, Thailand, France, Germany, Korea, Republic of, China, Malaysia, Hong Kong, Australia, Austria, Puerto Rico, Singapore, Canada, Portugal, Poland, Greece, United Kingdom and more
Clinical Trials on Methotrexate
-
University Hospital, MontpellierPfizer; Hôpital CochinCompletedRheumatoid ArthritisFrance, Monaco
-
Nicolaus Copernicus UniversityCompleted
-
Amneal Pharmaceuticals, LLCAccutest Research Laboratories (I) Pvt. Ltd.Unknown
-
Hee Young JuNot yet recruitingLymphoblastic Leukemia in Children
-
PfizerCompletedRheumatoid ArthritisUnited States, Mexico, Argentina, Chile, Croatia, Czech Republic, Hungary, Poland, Puerto Rico
-
PfizerCompletedRhematoid ArthritisSpain, United Kingdom, United States, Korea, Republic of, Poland, Israel, Australia, Taiwan, Thailand, South Africa, Bulgaria, Estonia, Latvia, Philippines, Canada, Romania, Russian Federation, Turkey, Mexico, Bosnia and Herzegovina and more
-
Cairo UniversityCompleted
-
Chugai Pharma TaiwanCompletedRheumatoid Arthritis (RA)Taiwan
-
CHA UniversityCompleted
-
Mitsubishi Tanabe Pharma CorporationCompleted