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A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients With Advanced Urothelial Cancer Progressing on or After a Platinum Containing Regimen
Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)
The purpose of this study is to evaluate the effects of nab-paclitaxel compared to paclitaxel in patients with advanced urothelial cancer.
Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with metastatic or locally advanced transitional cell carcinoma (TCC) of the urinary tract (bladder, urethra, ureter, renal, pelvis), which has progressed on or after a platinum containing regimen.
Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive intravenous infusions of the chemotherapy drug Paclitaxel every 21 days. Participants in the other group will receive intravenous infusions of the chemotherapy drug Nab-Paclitaxel every 21 days. Treatment will continue indefinitely as long as you are responding and able to tolerate the drug well.
All participants will be followed-up for up to 42 months in order to evaluate disease response, survival, toxicity, and quality of life. This research is being done because currently there is no effective treatment for advanced urothelial cancer that has progressed after prior chemotherapy.