Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy (Gemtrans)

This study is currently recruiting participants.
Verified April 2013 by Christie Hospital NHS Foundation Trust
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Suzanne Rowland, Christie Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01343121
First received: April 7, 2011
Last updated: April 26, 2013
Last verified: April 2013

April 7, 2011
April 26, 2013
January 2012
October 2014   (final data collection date for primary outcome measure)
Does response at Cystoscopy correlate with results of sample analysis [ Time Frame: 3 months following the end of GemX chemoradiation ] [ Designated as safety issue: No ]
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.
Does response at Cystoscopy correlate with results of sample analysis [ Time Frame: 3 months following the end of GemX chemoradiation ] [ Designated as safety issue: No ]

To test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of gemcitabine and its metabolites, 30 mins or 2 hours post-infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy.

Response at Cystoscopy is measured as either complete response, superficial disease or muscle-invasive disease.

Complete list of historical versions of study NCT01343121 on ClinicalTrials.gov Archive Site
  • cause-specific and overall survival rates [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • acute and late toxicities as assessed by RTOG and LENT SOM scales [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Toxicity is measured using LENT-SOMA (patient-reported) and CTCAE v4.0 (clinical assessment) during treatment and at follow up.
Same as current
Not Provided
Not Provided
 
Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy
Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy

The purpose of this study is to test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of Gemcitabine and its metabolites, 30 mins or 2 hours post infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy.

Not Provided
Interventional
Not Provided
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Bladder Cancer
  • Other: sample collection
    Blood samples will be collected on days 1, 8, 15 and 22. They will be taken 30 minutes and 2 hours post Gemcitabine infusion.
  • Other: sample collection
    Urine will be collected on days 1, 8, 15 and 22. They will be taken pre gemcitabine and 2 hours post Gemcitabine
  • Other: Sample Collection
    Quality of Life (QOL) questionnaires given to the patient at each visit
sample collection

This is a single arm study. Patients will be seen on day 1, 8, 15 and 22 and will have the following samples collected:

  • Pre gemcitabine urine sample
  • Blood sample 30 minutes post Gemcitabine infusion
  • Urine and blood sample 2 hours post Gemcitabine infusion
Interventions:
  • Other: sample collection
  • Other: sample collection
  • Other: Sample Collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • histologically confirmed diagnosis of muscle-invasive transitional cell carcinoma.
  • suitable for treatment with radical concurrent chemoradiotherapy with GemX.
  • Standard radiological assessments with CT or MR for staging.
  • ECOG performance status 0-2
  • Adequate pre-treatment haematological and biochemical parameters
  • Age greater than or equal to 18 years
  • No significant co-morbidity thereby excluding patient from having radical treatment.
  • No previous treatment for diagnosis of muscle-invasive bladder cancer or other pelvic radiotherapy.
  • Women of child bearing age MUST have a negative pregnancy test prior to study entry and be using an adequate contraception method, which must be continued for 3 months after the study, unless child bearing potential has been terminated by surgery/radical radiotherapy
  • Patients must have given written informed consent

Exclusion Criteria:

  • Patients with a known history of anaphylactic reaction to any other drug.
  • Patients must not have a history of other malignant diseases other than adequately treated non-melanotic skin cancer or in-situ carcinoma of the uterine cervix
  • Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial.
  • Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial Any other serious uncontrolled medical conditions
  • Clinical evidence of metastatic disease to brain
  • Any pregnant or lactating woman
  • Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
Both
18 Years and older
No
Contact: Ananya Choudhury, Phd 0161 446 3000 ananya.choudhury@christie.nhs.uk
Contact: Suzanne Rowland, BSc 01614463308 suzanne.rowland@christie.nhs.uk
United Kingdom
 
NCT01343121
10_DOG04_124
No
Suzanne Rowland, Christie Hospital NHS Foundation Trust
Christie Hospital NHS Foundation Trust
University of Oxford
Principal Investigator: Ananya Choudhury, Phd The Christie NHS Foundation Trust
Christie Hospital NHS Foundation Trust
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP