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

The Christie NHS Foundation Trust

Status: Completed

Conditions: Bladder Cancer

Treatments: Other: Sample Collection; Other: sample collection

Study type: Interventional

Funder types: Other

Identifiers

NCT01343121

10_DOG04_124

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

sample collection

Other group

Description:

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

Treatment:

Other: sample collection

Other: sample collection