Clinical Trials Logo
  1. Home
  2. Metastatic Urothelial Cancer
  3. NCT02240017

A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function. — VEFORA  

Metastatic Urothelial Cancer Clinical Trial

Official title:
Randomized, Multicenter, Phase II/III Study, Evaluating Fractionated Cisplatin Chemotherapy/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.

Clinical Trial Summary

This is a phase II/III, multicenter, randomized study which includes 420 patients on six years + 3 years follow up. 92 patients will be included during the phase II ; additional 328 patients will be included.

Patients with an advanced or metastatic urothelial cancer with impaired renal function will be randomized in one of the two following chemotherapy arm:

- Fractionated Cisplatin + Gemcitabine.

- Carboplatin + Gemcitabine.

The main objective of the part II study will be to evaluate the efficacy and the safety of a chemotherapy with a doublet platinum salt compound/Gemcitabine with fractionated Cisplatin or Carboplatin in this population.

The main objective of the part III study will be to compare the efficacy in terms of overall survival of a chemotherapy with a doublet platinum salt/Gemcitabine with fractionated Cisplatin or Carboplatin in this population.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02240017
Study type Interventional
Source Institut Claudius Regaud
Contact
Status Completed
Phase Phase 2/Phase 3
Start date January 21, 2015
Completion date July 15, 2019
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03682068 - Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer Phase 3
Recruiting NCT05101096 - Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT02826564 - Trial of Stereotactic Body Radiotherapy With Concurrent Pembrolizumab in Metastatic Urothelial Cancer Phase 1
Completed NCT01963052 - ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer Phase 1
Not yet recruiting NCT05390645 - A Study of MFA-370 in Patients With Metastatic Urothelial Cancer Phase 1/Phase 2
Recruiting NCT03745911 - Paclitaxel and TAK-228 in Urothelial Carcinoma Phase 2
Completed NCT03390595 - Avelumab Plus Carboplatin-gemcitabine in Urothelial Carcinoma Phase 2
Active, not recruiting NCT03451331 - Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer Phase 2
Active, not recruiting NCT04995419 - A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy Phase 2
Completed NCT03679767 - A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203) Phase 2
Recruiting NCT06225596 - Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) Phase 2/Phase 3
Recruiting NCT03547973 - Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread Phase 2
Completed NCT03070990 - A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Phase 1
Completed NCT03448718 - Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations Phase 2