Status:
COMPLETED
Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer
Lead Sponsor:
Amgen
Conditions:
Recurrent and/or Metastatic Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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 \[without monitoring program\])
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
658 Patients enrolled
Trial Details
Trial ID
NCT00460265
Start Date
May 1 2007
End Date
May 1 2012
Last Update
March 7 2014
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