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

Phase 3

Completed

• Conditions: Recurrent and/or Metastatic Head and Neck Cancer
• Interventions: Drug: ARM 2; Drug: ARM 1

• Registration Number: NCT00460265
• Lead Sponsor: Amgen

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 cell carcinoma of the head and neck.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-12
• Study First Submitted QC: 2007-04-12
• Study First Posted: 2007-04-13
• Study Start: 2007-05
• Primary Completion: 2010-05
• Results First Submitted: 2011-05-13
• Results First Submitted QC: 2011-05-13
• Results First Posted: 2011-06-14
• Study Completion: 2012-05
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 658

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])

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM 2	ARM 2	Arm 2 consists of Cisplatin and 5-FU
ARM 1	ARM 1	ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU

Primary Outcome Measures

Name	Time	Method
Overall Survival	Upto 56 months	Time from randomization to death

Secondary Outcome Measures

Name	Time	Method
Duration of Response	Every 6 weeks until disease progression, up to 56 months	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).
Time to Progression	Every 6 weeks until disease progression, up to 56 months	Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)
Time to Response	Every 6 weeks until disease progression, upto 56 months	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.
Progression Free Survival	Every 6 weeks until disease progression or deaths, upto 56 months	Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.
Overall Response Rate	Every 6 weeks until disease progression, up to 56 months	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.