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