Overview

PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response

Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
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