drugset / Trial / NCT00454779
PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.
Timeline
- Start
- 2007-01-01
- Primary completion
- 2012-06-11
- Completion
- 2014-01-01
Outcome
Met primary endpoint
registry analysis (superiority or other test); Panitumumab Plus Chemotherapy vs Chemotherapy Alone; p = 0.048; Log Rank NCT00454779 ↗
Publications
- Background Wirth LJ. PARTNER: a study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer. Commun Oncol. 2008;5(Supp 14):1-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Panitumumab | Monoclonal antibody | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Docetaxel | Small molecule | — | — |