NCT01599013

JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin

Randomized Phase II Study Assessing the Combination of Vinflunine With Gemcitabine and Vinflunine With Carboplatin in Patients Ineligible to Cisplatin With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This study is assessing the combination of well known cytotoxics with a novel anti-cancer agent that could be administered as monotherapy without renal toxicity in patients with renal impairment presenting with advanced or metastatic urothelial carcinoma previously treated with a platinum-based regimen. The intent of this study is to clarify the benefit/risk ratio of the two most promising associations of cytotoxics including the novel therapeutic agent, vinflunine: vinflunine-gemcitabine and vinflunine-carboplatin.

Detailed description

Gemcitabine and carboplatin have been the most studied and used anticancer agents in cisplatin-unfit patients with advanced urothelial carcinoma. Both agents previously demonstrated clinical activity as single agent and/or as part of combination regimen in patients with advanced or metastatic disease even if clinical benefits and survival remains limited in this setting for this population. The purpose of this study is to test in a randomized trial enrolling patients with renal impairment or moderate congestive heart failure two combinations of a novel cytotoxic agent, vinflunine, one with gemcitabine and another with carboplatin in order to determine the most promising combination in the first line treatment of advanced/metastatic urothelial carcinoma.

Conditions

• Bladder Transitional Cell Carcinoma Stage IV

Interventions

Type	Name	Description
DRUG	Vinflunine, Gemcitabine	* Vinflunine 280 or 250 mg/m2, IV administration over 20 minutes (starting dose based on baseline creatinine clearance value), Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal * Gemcitabine 750 or 1000 mg/m2, IV administration over 30 minutes (starting dose based on baseline creatinine clearance value), Day 1 and 8 every 3 weeks up to progression or unacceptable toxicity or patient's refusal
DRUG	Vinflunine, Carboplatin	* Vinflunine 280 or 250 mg/m2, IV administration over 20 minutes (starting dose based on baseline creatinine clearance value), Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal * Carboplatin AUC 4.5, IV administration over 60 minutes, Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-10-01
• Completion: 2014-04-01
• First posted: 2012-05-15
• Last updated: 2015-12-08

Locations

1 site across 1 country: France