Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Does response at Cystoscopy correlate with results of sample analysis
To test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of gemcitabine and its metabolites, 30 mins or 2 hrs post-infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy. Gemcitabine will be measured in plasma by HPLC-MS using a published validated method. We have developed an assay for intracellular gemcitabine triphosphate which should determine levels in PBMCs from 10 - 15 ml blood. Response at Cystoscopy is measured as either complete response, superficial disease or muscle-invasive disease.
3 months following the end of GemX chemoradiation
Ananya Choudhury, Phd
The Christie NHS Foundation Trust
United Kingdom: National Health Service