Bladder Cancer Clinical Trial
Official title:
An Exploratory Phase I Study With Sorafenib in Addition to Vinflunine in Progressive Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract
This study aims to analyse the tolerability (side effects and safety) with standard treatment (Javlor®) with the addition of a second anti-tumour drug: sorafenib (Nexavar®). This is the first time this treatment combination is studied in humans. Samples of blood, urine and tumour tissues will be analysed for molecular biomarkers. These biomarkers may potentially help us in the future in predicting whether a patient will benefit or not from the cancer treatment. The study also aims to investigate if a newer imaging method, called PET-CT (positron emission tomography-computed tomography), at an earlier stage (than a normal CT scan) can identify patients who will benefit from the given treatment.
Objectives
- To explore the safety of sorafenib in combination with vinflunine in patients with
transitional cell carcinoma of the urothelial tract and to define a recommended phase II
dose for this treatment combination
- To correlate early tracer 18F-FDG-PET/CT functional imaging readouts with standard
RECIST (version 1.1) evaluations with the intention to explore new endpoints for
targeted therapy
- To find predictive tumour tissue biomarkers for sorafenib/vinflunine treatment
- To evaluate serum and urine markers of apoptosis as potential markers of
sorafenib/vinflunine treatment
Rationale/Goal
To evaluate the tolerability and activity of sorafenib combined with vinflunine in patients
with advanced or metastatic urothelial cancer.
Tumour biopsies will be collected before and after one cycle of therapy. The translational
part of this study aims to explore the predictive value of a number of biomarkers related to
the targeted properties of sorafenib and presumptive markers for vinflunine treatment.
In addition, the predictive value of an early functional imaging tracer 18F-FDG-PET/CT will
be evaluated.
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