NCT02665039

A Trial With Vinflunine in Patients With Metastatic Bladder Cancer and Impaired Renal Function

A Multicenter, Randomized Phase II Trial of Vinflunine/Gemcitabine vs Carboplatin/Gemcitabine as First Line Treatment in Patients With Metastatic Urothelial Carcinoma Unfit for Cisplatin Based Chemotherapy Due to Impaired Renal Function.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Dr Anders Ullén · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aim to compare the efficacy, safety and quality of life of vinflunine/gemcitabine and carboplatin/gemcitabine in patients with metastatic urothelial cancer and impaired renal function.

Detailed description

Rational The standard first line treatment for patients with metastatic urothelial carcinoma unfit for cisplatin due to renal impairment is carboplatin containing chemotherapy, with a median overall survival of approximately 8-10 month. New, more effective regimens in terms of tumor control and quality of life are urgently needed. Vinflunine has proven efficacy in urothelial carcinoma and is registered as second line treatment. The combination of gemcitabine and vinflunine has not yet been evaluated in first line treatment for patients with metastatic urothelial carcinoma. Objectives * To compare the progression free survival (FPS) of vinflunine/gemcitabine versus carboplatin/gemcitabine in patients with locally advanced or metastatic transitional cell carcinoma of the urothelial tract unfit for cisplatin based chemotherapy due to impaired renal function. * To evaluate the tumour response (ORR), overall survival (OS) and disease control rate (DCR) of vinflunine/gemcitabine versus carboplatin/gemcitabine * To assess the safety and toxicity of vinflunine/gemcitabine versus carboplatin/gemcitabine. * To investigate and compare Quality of life during treatment with vinflunine/gemcitabine and carboplatin/gemcitabine respectively.

Conditions

• Urothelial Carcinoma
• Bladder Cancer
• Renal Pelvis Cancer
• Ureter Cancer
• Urethra Cancer

Interventions

Type	Name	Description
DRUG	Vinflunine	Vinflunine will be given intravenously once every 21 days, starting at a dose of: * 280 mg/m2 in patients with GFR 40-60 ml/min * 250 mg/m2 in patients aged \>80 years and/or GFR 30-40 ml/min
DRUG	Gemcitabine	Gemcitabine will be given intravenously on day 1 and day 8 of every 21 day cycle, starting at a dose of 1000 mg/m2
DRUG	Carboplatin	Carboplatin will be given intravenously once every 21 days, starting at a dose of AUC 4.5

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2016-01-27
• Last updated: 2019-10-08

Locations

2 sites across 2 countries: Denmark, Sweden