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

Bladder Cancer Clinical Trial

— Gemtrans  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343121
• Other study ID #: 10_DOG04_124
• Status: Completed
• Phase: N/A
• Start date: February 2, 2012
• Est. completion date: November 24, 2017

Study information

• Verified date: August 2021
• Source: The Christie NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 24, 2017
• Est. primary completion date: November 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.
• sample collection
Urine will be collected on days 1, 8, 15 and 22. They will be taken pre gemcitabine and 2 hours post Gemcitabine
• Sample Collection
Quality of Life (QOL) questionnaires given to the patient at each visit

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester	Gtr Manchester

Sponsors (2)

Lead Sponsor	Collaborator
The Christie NHS Foundation Trust	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	cause-specific and overall survival rates		3 years
Secondary	acute and late toxicities as assessed by RTOG and LENT SOM scales	Toxicity is measured using LENT-SOMA (patient-reported) and CTCAE v4.0 (clinical assessment) during treatment and at follow up.	3 years