Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer (SPECTRUM)

Amgen

Status and phase

Completed

Phase 3

Conditions

Recurrent and/or Metastatic Head and Neck Cancer

Treatments

Drug: ARM 1

Drug: ARM 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT00460265

20050251

Details and patient eligibility

About

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.

Enrollment

658 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion criteria

History or known presence of Central Nervous System (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 (Epidermal growth factor receptor) 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 computerized tomography (CT) scan.
Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0
Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Auditory/Ear (Hearing [without monitoring program])