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

NCT01343121 | Completed

• 1 other identifier: 10_DOG04_124
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

Radiotherapy; GemX Chemoradiotherapy; Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• cause-specific and overall survival rates

  3 years

• acute and late toxicities as assessed by RTOG and LENT SOM scales

  3 years

Study Arms (1)

sample collection

OTHER

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

Interventions

Sample Collection OTHER

Blood samples will be collected on days 1, 8, 15 and 22. They will be taken 30 minutes and 2 hours post Gemcitabine infusion.

sample collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• University of Oxford: collaborator

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, Gtr Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Ananya Choudhury, Phd

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 27, 2011
• Study Start: February 2, 2012
• Primary Completion: November 24, 2017
• Study Completion: November 24, 2017
• Last Updated: August 13, 2021

Record last verified: 2021-08

Locations

GB (1)