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

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)

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.

Study Overview

• Status: Completed
• Conditions: Recurrent and/or Metastatic Head and Neck Cancer
• Intervention / Treatment: Drug: ARM 2; Drug: ARM 1

• Study Type: Interventional
• Enrollment (Actual): 658
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Bach B, et al.SPECTRUM biomarkers HPV.Journal-004521;
• Vermorken JB, Stohlmacher-Williams J, Davidenko I, Licitra L, Winquist E, Villanueva C, Foa P, Rottey S, Skladowski K, Tahara M, Pai VR, Faivre S, Blajman CR, Forastiere AA, Stein BN, Oliner KS, Pan Z, Bach BA; SPECTRUM investigators. Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial. Lancet Oncol. 2013 Jul;14(8):697-710. doi: 10.1016/S1470-2045(13)70181-5. Epub 2013 Jun 6.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: April 12, 2007
• First Submitted That Met QC Criteria: April 12, 2007
• First Posted (Estimate): April 13, 2007

Study Record Updates

• Last Update Posted (Estimate): March 7, 2014
• Last Update Submitted That Met QC Criteria: February 3, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Squamous Cell Carcinoma; Epidermal Growth Factor Receptor; SCCHN; EGFr; Epidermal Growth Factor; Recurrent Head and Neck Cancer; Metastatic Head and Neck Cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Head and Neck Neoplasms; Recurrence
• Other Study ID Numbers: 20050251