drugset / Trial / NCT01487915

Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma

NCT01487915 ↗

Phase 2 Unknown 80 enrolled Asan Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma. But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice. Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb) with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities. But the grade 3 or worse toxicities associated with GCb are not infrequent and need more effective and more tolerable regimens. GemOx has been reported to be effective and have very favorable toxicity profiles.

Timeline

Start
2010-10
Primary completion
2015-06
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 4.5 unknown —
Subject Gemcitabine Small molecule 1000 mg/m2 —
Subject Oxaliplatin Small molecule 100 mg/m2 —

Indications