Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Recurrent and/or Metastatic Head and Neck Cancer	Drug: ARM 2 Drug: ARM 1	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: head and neck squamous cell carcinoma

MedlinePlus related topics: Head and Neck Cancer

Drug Information available for: Panitumumab

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Overall Survival [ Time Frame: Upto 56 months ] [ Designated as safety issue: No ]
Time from randomization to death

Secondary Outcome Measures:

Overall Response Rate [ Time Frame: Every 6 weeks until disease progression, up to 56 months ] [ Designated as safety issue: No ]
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.
Duration of Response [ Time Frame: Every 6 weeks until disease progression, up to 56 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 6 weeks until disease progression, up to 56 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 6 weeks until disease progression, upto 56 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 6 weeks until disease progression or deaths, upto 56 months ] [ Designated as safety issue: No ]
Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.


Enrollment:	658
Study Start Date:	May 2007
Study Completion Date:	May 2012
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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])

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460265

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

Bach B, et al.SPECTRUM biomarkers HPV.Journal-004521;

Vermorken JB, Stöhlmacher-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.


Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT00460265 History of Changes
Other Study ID Numbers:	20050251
Study First Received:	April 12, 2007
Results First Received:	May 13, 2011
Last Updated:	February 3, 2014
Health Authority:	Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica) Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee Austria: Bundesamt für Sicherheit im Gesundheitswesen Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment Brazil: ANVISA (Agência Nacional de Vigilância Sanitária) Bulgaria: Bulgarian Drug Agency Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe Hong Kong: Department of Health Hungary: National Institute of Pharmacy India: Central Drugs Standard Control Organization Ireland: Irish Medicines Board Spain: Agencia Española de Medicamentos y Productos Sanitarios Italy: Ministry of Health Mexico: Ministry of Health Sweden: Medical Products Agency Switzerland: Swissmedic (Swiss Agency for Therapeutic Products) Ukraine: Pharmacological Centre at the Ministry of Health of the Ukraine (Pharma Centre) United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration United States: Institutional Review Board Mexico: SSA (Secretaria de Salud Publica) Peru: INS (Instituto Nacional de Salud) Poland: Drug Institut Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED) Romania: Romanian National Drug Agency Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health) Singapore: Health Science Authority South Korea: Korea Food & Drug Administration

Keywords provided by Amgen:


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

Additional relevant MeSH terms:


Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell	Neoplasms by Site Cisplatin Antibodies, Monoclonal Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016

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