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)

Amgen0 sites658 target enrollmentMay 2007

ConditionsRecurrent and/or Metastatic Head and Neck Cancer

InterventionsARM 2 ARM 1

DrugsARM 2 ARM 1

Overview

Phase: Phase 3
Intervention: ARM 2
Conditions: Recurrent and/or Metastatic Head and Neck Cancer
Sponsor: Amgen
Enrollment: 658
Primary Endpoint: Overall Survival
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2007

End Date

May 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

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.
•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 \[without monitoring program\])

Arms & Interventions

ARM 2

Arm 2 consists of Cisplatin and 5-FU

Intervention: ARM 2

ARM 1

ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU

Intervention: ARM 1

Outcomes

Primary Outcomes

Overall Survival

Time Frame: Upto 56 months

Time from randomization to death

Secondary Outcomes

Duration of Response(Every 6 weeks until disease progression, up to 56 months)
Time to Progression(Every 6 weeks until disease progression, up to 56 months)
Time to Response(Every 6 weeks until disease progression, upto 56 months)
Progression Free Survival(Every 6 weeks until disease progression or deaths, upto 56 months)
Overall Response Rate(Every 6 weeks until disease progression, up to 56 months)