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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Christie Hospital NHS Foundation Trust
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Rebecca Robinson, Christie Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01343121
First received: April 7, 2011
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Bladder Cancer
Other: sample collection
Other: Sample Collection

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy

Resource links provided by NLM:


Further study details as provided by Christie Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01343121

Contacts
Contact: Ananya Choudhury, Phd 0161 446 3000 ananya.choudhury@christie.nhs.uk
Contact: Rebecca Robinson, PhD 01619187945 rebecca.robinson2@christie.nhs.uk

Locations
United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, Gtr Manchester, United Kingdom, M20 4BX
Contact: Ananya Choudhury, Phd    01614468323    ananya.choudhury@christie.nhs.uk   
Contact: Suzanne Rowland, BSc    01614463308    suzanne.rowland@christie.nhs.uk   
Principal Investigator: Ananya Choudhury, Phd         
Sponsors and Collaborators
Christie Hospital NHS Foundation Trust
University of Oxford
Investigators
Principal Investigator: Ananya Choudhury, Phd The Christie NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Rebecca Robinson, Clinical Trials Project manager, Christie Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01343121     History of Changes
Other Study ID Numbers: 10_DOG04_124
Study First Received: April 7, 2011
Last Updated: July 22, 2014
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Christie Hospital NHS Foundation Trust:
Radiotherapy
GemX Chemoradiotherapy
Bladder Cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014