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. (VINGEM)

NCT02665039 Phase 2 COMPLETED

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.

Details

Lead sponsor	Dr Anders Ullén
Phase	Phase 2
Status	COMPLETED
Enrolment	62
Start date	2014-04
Completion	2018-09

Conditions

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

Interventions

• Vinflunine
• Gemcitabine
• Carboplatin

Primary outcomes

• Progression-free survival (PFS) — From randomization through study completion, on average within 9 months
  Defined as the duration from randomization to either confirmed progression (by RECIST) or death from any cause.

Countries

Denmark, Sweden