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

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

History of Changes

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 Non-randomised Phase II Trial of Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Methotrexate Methotrexate sodium

U.S. FDA Resources

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:

study subjects will receive methotrexate intravenously on day 1 and day 8 of a 3 weekly cycle.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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

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


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:	December 3, 2013
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 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 September 23, 2016

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