Conditions: Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
Keywords: SCCHNC Metastatic Recurrent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 113
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Panitumumab + Docetaxel + Cisplatin arm 2: control

Interventions: intervention 1: Cisplatin intervention 2: Panitumumab intervention 3: Docetaxel intervention 4: Cisplatin intervention 5: Docetaxel
Intervention descriptions: intervention 1: chemotherapy arm intervention 2: experimental arm intervention 3: chemotherapy arm intervention 4: experimental arm intervention 5: experimental arm

Protocol document: