drugset / Trial / NCT01490437
Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |