Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer (SPECTRUM)
This study has been completed.
Information provided by (Responsible Party):
First received: April 12, 2007
Last updated: February 3, 2014
Last verified: February 2014
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.
Recurrent and/or Metastatic Head and Neck Cancer
Drug: ARM 2
Drug: ARM 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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)
Primary Outcome Measures:
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2010 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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])
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460265
No publications provided by Amgen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 12, 2007
|Results First Received:
||May 13, 2011
||February 3, 2014
||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
Metastatic Head and Neck Cancer
Head and Neck Cancer
Recurrent Head and Neck Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site