drugset / Trial / NCT02818725
I-MVAC +/- Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma Without H-Ras Nor K-Ras Mutations
RandomizedParallel-groupOpen-labelTreatment
Summary
OBJECTIVES OF THE TRIAL Primary objective Evaluation of efficacy in terms of progression-free survival at 9 months of the combination of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations. Secondary objectives * To assess toxicity * To assess response rate * To assess overall survival * To assess time to progression * To study the correlation between response rate, time to progression, overall survival and biological parameters
Timeline
- Start
- 2010-06
- Primary completion
- 2016-09
- Completion
- 2017-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Panitumumab | Monoclonal antibody | 6 mg/kg | — |
| Background | Cisplatin | Other / unclassified | 70 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | 30 mg/m2 | — |
| Background | Methotrexate | Small molecule | 30 mg/m2 | — |
| Background | Vinblastine | Small molecule | 3 mg/m2 | — |