Overview
PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response
Status:
Completed
Completed
Trial end date:
2014-01-01
2014-01-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AmgenTreatments:
Antibodies, Monoclonal
Cisplatin
Docetaxel
Panitumumab
Criteria
Inclusion Criteria:- Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell
Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or
radiation therapy.
- Measurable disease by CT scan
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Age: 18 years or older
- Adequate hematologic, renal, metabolic, hepatic & thyroid function
Exclusion Criteria:
- Prior systemic treatment for metastatic and/or recurrent SCCHN
- CNS metastases, or nasopharyngeal carcinoma
- History of interstitial lung disease
- History of another primary cancer
- Any co-morbid disease that would increase risk of toxicity
- Active infection requiring systemic treatment
- Prior anti-Epidermal Growth Factor receptor (anti-EGFr) antibody therapy