MESH

• Research type

  Research Study

• Full title

  MESH: A Non-Randomised Phase II Trial of Methotrexate in metastatic Colorectal Cancer with MSH2 deficiency

• IRAS ID

  111111

• Sponsor organisation

  Royal Marsden Hospital NHS Trust

• Eudract number

  2008-000524-82

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a clinical trial to assess how effective the chemotherapy drug methotrexate is in treating patients with advanced bowel cancer who have a deficiency in a particular gene, calledMSH2. It is classified as a phase II, non-randomised trial. Patients must have this deficiency identified by tests on tumour samples or blood before they can enter the trial. Patients who enter this study will all receive methotrexate, given by injection (intravenously). Treatment will be given once a week for two weeks, followed by a week off. The length of treatment will depend on the clinical benefit and the side effects of treatment, but it is anticipated that in patients who benefit treatment will be continued for 6 cycles. This study is designed for patients whose cancer is resistant to standard chemotherapy for bowel cancer. Response to treatment will be measured using CT scans and clinical assessment. Side effects from treatment and quality of life will also be assessed. During a patient's time on the trial, urine and hair follicle samples will be taken for research testing, with the aim of identifying substances in the tissue samples which can predict for a response to treatment.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  08/H0907/110

• Date of REC Opinion

  9 Oct 2008

• REC opinion

  Further Information Favourable Opinion