Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over Pharmaceutical / Industry 20050251 SPECTRUM, 20050251, NCT00460265

Trial Description

Summary

The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.

Eligibility Criteria

Inclusion Criteria:

• Man or woman at least 18 years old.

• Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck.

• Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy.

• Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy.

• Measurable and non-measurable disease.

• ECOG performance status of 0 or 1.

Exclusion Criteria:

• History or known presence of CNS metastases.

• History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization.

• Nasopharyngeal carcinoma.

• Prior systemic treatment for metastatic and/or recurrent SCCHN

• Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy

• Prior anti-EGFr antibody therapy or treatment with small molecule EGFr inhibitors

• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year prior to randomization. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan.

• Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0

• Grade ≥ 3 hearing loss based on the CTCAE v3.0 Auditory/Ear (Hearing [without monitoring program])

Trial Contact Information

Trial Lead Organizations/Sponsors

Amgen, Incorporated

MD

Study Director

Amgen Call Center

Ph: 866-572-6436

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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00460265
Information obtained from ClinicalTrials.gov on January 08, 2009