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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Conditions
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Recurrent and/or Metastatic Head and Neck Cancer

Intervention / Treatment
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* Drug: ARM 2
* Drug: ARM 1


Participation Criteria
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Eligibility Criteria
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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])

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ARM 2<br>Arm 2 consists of Cisplatin and 5-FU | Drug: ARM 2<br>* Subjects will receive Cisplatin plus 5FU<br>|
| Experimental: ARM 1<br>ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU | Drug: ARM 1<br>* Subjects will receive Panitumumab plus cisplatin and 5FU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Time from randomization to death | Upto 56 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size. | Every 6 weeks until disease progression, up to 56 months | 
| Duration of Response | Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H). | Every 6 weeks until disease progression, up to 56 months | 
| Time to Progression | Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H) | Every 6 weeks until disease progression, up to 56 months | 
| Time to Response | Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0. | Every 6 weeks until disease progression, upto 56 months | 
| Progression Free Survival | Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death. | Every 6 weeks until disease progression or deaths, upto 56 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Squamous Cell Carcinoma, Epidermal Growth Factor, Epidermal Growth Factor Receptor, SCCHN, Metastatic Head and Neck Cancer, EGFr, Head and Neck Cancer, Recurrent Head and Neck Cancer