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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00460265

First received: April 12, 2007

Last updated: June 30, 2011

Last verified: June 2011

History of Changes

Results First Received: May 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Recurrent and/or Metastatic Head and Neck Cancer
Interventions:	Drug: ARM 2 Drug: ARM 1

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled from 25 May 2007 to 10 March 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Panitumumab Plus Chemotherapy	Consists of Panitumumab plus Cisplatin and 5-FU
Chemotherapy Alone	Consists of Cisplatin and 5-FU

Participant Flow: Overall Study

	Panitumumab Plus Chemotherapy	Chemotherapy Alone
STARTED	328	330
Randomized While Alive	327 ^[1]	330
Received Study Medication	325	325
COMPLETED	243 ^[2]	241 ^[2]
NOT COMPLETED	85	89
Lost to Follow-up	14	15
Physician Decision	1	2
Withdrawal by Subject	10	25
Ongoing	60	47

[1]	1 subject was randomized by error after death
[2]	Completed study=death

Baseline Characteristics

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Reporting Groups

	Description
Panitumumab Plus Chemotherapy	Consists of Panitumumab plus Cisplatin and 5-FU
Chemotherapy Alone	Consists of Cisplatin and 5-FU
Total	Total of all reporting groups

Baseline Measures

	Panitumumab Plus Chemotherapy	Chemotherapy Alone	Total
Number of Participants [units: participants]	327	330	657
Age [units: years] Mean ± Standard Deviation	57.6 ± 8.5	58.6 ± 7.8	58.1 ± 8.2
Gender [units: subjects]
Female	44	43	87
Male	283	287	570
Race/Ethnicity, Customized [units: subjects]
White or Caucasian	268	271	539
Black or African American	4	2	6
Hispanic or Latino	13	12	25
Asian	25	30	55
Japanese	13	7	20
Aborigine	1	0	1
Other	3	6	9
Unknown/Missing	0	2	2
Previously treated with chemotherapy and/or radiotherapy, Yes/No [units: subjects]
Yes	267	263	530
No	60	67	127
ECOG perfomance score, 0/1/2 [units: subjects]
0	98	98	196
1	227	228	455
2	2	4	6
Primary tumor site, oropharynx&larynx/oral cavity&hypopharynx [units: subjects]
Oropharynx and larynx	186	191	377
Oral cavity and hypopharynx	141	139	280

Outcome Measures

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1. Primary:

Overall Survival [ Time Frame: Upto 56 months ]

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2. Secondary:

Overall Response Rate [ Time Frame: Every 6 weeks until disease progression, up to 56 months ]

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3. Secondary:

Duration of Response [ Time Frame: Every 6 weeks until disease progression, up to 56 months ]

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4. Secondary:

Time to Progression [ Time Frame: Every 6 weeks until disease progression, up to 56 months ]

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5. Secondary:

Time to Response [ Time Frame: Every 6 weeks until disease progression, upto 56 months ]

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6. Secondary:

Progression Free Survival [ Time Frame: Every 6 weeks until disease progression or deaths, upto 56 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00460265 History of Changes
Other Study ID Numbers:	20050251, SPECTRUM, 20050251
Study First Received:	April 12, 2007
Results First Received:	May 13, 2011
Last Updated:	June 30, 2011
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

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