Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer (SPECTRUM)
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00460265
First received: April 12, 2007
Last updated: February 3, 2014
Last verified: February 2014
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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
Genetic and Rare Diseases Information Center resources:
Squamous Cell Carcinoma of the Head and Neck
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 |
| 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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460265
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided by Amgen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
|
Head and Neck Neoplasms Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on February 27, 2015