drugset / Trial / NCT01285778
Vectibix for the Treatment of Anal Cancer
Phase 2
Completed
58 enrolled
Grupo Espanol Multidisciplinario del Cancer Digestivo
Amgen · collabTrial Form Support S.L. · collab
NaSingle-groupOpen-labelTreatment
Summary
Chemoradiation with 5-FU and Mitomycin C is the standard treatment in anal canal SCC. Panitumumab has shown efficacy in other tumors and anti-EGFR treatment has shown clinical activity in a single report of a refractory anal canal SCC patient. Based on this background, we propose to conduct a phase II study to investigate the efficacy and toxicity of radiotherapy with the association: * 5-FU 1000mg/m2 on days 1-4 and 29-32 * Mitomycin C 10mg/m2 on days 1 and 29 * Panitumumab 6 mg/kg on day 1, then every 2 weeks for 8 weeks
Timeline
- Start
- 2010-10
- Primary completion
- 2017-03-24
- Completion
- 2017-03-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitomycin C | Other / unclassified | 10 mg/m2 | — |
| Subject | Panitumumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | fluorouracil | Small molecule | 1000 mg/m2 | — |