drugset / Trial / NCT01490437

Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma

NCT01490437

Phase 2 Completed 42 enrolled Asan Medical Center
NaSingle-groupOpen-labelTreatment

Summary

Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single agent as first-line and second-line treatment for advanced urothelial carcinoma. The response rates were 32% and 28% for the first-line and second-line setting, respectively. Cisplatin is one the most active chemotherapeutic agents in urothelial cancer, frequently used as combination chemotherapy such as GP (gemcitabine plus cisplatin) or MVAC (methotrexate, vinblastine, adriamycin, and cisplatin). Pemetrexed and cisplatin showed favorable activity profile in advanced non-small cell lung cancer with highly favorable toxicity profile. This study is to assess the efficacy and safety of pemetrexed plus cisplatin in advanced urothelial carcinoma.

Timeline

Start
2008-07
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 70 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous
Background Dexamethasone Small molecule 4 mg Oral
Background Vitamin B12 Other / unclassified 1000 ug
Background folic acid Other / unclassified 350 ug
Background folic acid Other / unclassified 600 ug

Indications