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


N/A
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Does response at Cystoscopy correlate with results of sample analysis

Outcome Description:

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.

Outcome Time Frame:

3 months following the end of GemX chemoradiation

Safety Issue:

No

Principal Investigator

Ananya Choudhury, Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Christie NHS Foundation Trust

Authority:

United Kingdom: National Health Service

Study ID:

10_DOG04_124

NCT ID:

NCT01343121

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Radiotherapy
  • GemX Chemoradiotherapy
  • Bladder Cancer
  • Urinary Bladder Neoplasms

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