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

Completed · Phase 2

Conditions studied: Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck

In brief

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.

Key facts

Study ID

NCT00454779

Run by

Amgen

People needed

113

Starts

2007-01-01

Expected to finish

2014-01-01

Last updated by the study team

2018-10-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Jonesboro, Arkansas, United States
• Research Site — Duarte, California, United States
• Research Site — La Jolla, California, United States
• Research Site — La Verne, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Santa Cruz, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Norwich, Connecticut, United States
• Research Site — Newark, Delaware, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Lakeland, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — New Port Richey, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Athens, Georgia, United States
• Research Site — Griffin, Georgia, United States
• Research Site — Marietta, Georgia, United States
• Research Site — Centralia, Illinois, United States
• Research Site — Elk Grove Village, Illinois, United States
• Research Site — Evanston, Illinois, United States
• Research Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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