Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00547157

Purpose

The purpose of this study is to estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN). A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.

Condition	Intervention	Phase
Cancer Head and Neck Cancer Oncology Squamous Cell Carcinoma	Drug: Panitumumab Drug: Cisplatin	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin Epidermal Growth Factor Panitumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Further study details as provided by Amgen:

Primary Outcome Measures:

Efficacy: LRC rate at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy: PFS, OS, duration of LRC, LRC at 6 months and 1 year, rate of CR by 6 months, ORR by 6 months. Safety: Incidence of early death (on or within 30 days of last protocol-defined treatment) [ Time Frame: LRC at 6 months and 1 year, rate of CR by 6 months, ORR by 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ARM 1 CRT: Active Comparator Cisplatin plus RT	Drug: Cisplatin Cisplatin
ARM 2 PRT: Experimental Panitumumab plus RT	Drug: Panitumumab Arm 2 consists of panitmumab plus RT

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed SCC of the oral cavity, oropharynx, hypopharynx or larynx Stage III or Stage IVa-b (M0) disease according to the American Joint Committee on Cancer staging manual 6th edition (locally advanced) ECOG performance status of 0 or 1 Bidimensionally measurable disease >/= 10 mm in at least 1 dimension

Exclusion Criteria:

NO Primary tumor of the nasopharynx, sinuses, salivary gland, or skin NO Subjects requiring prophylactic tracheostomy NO Prior (or concomitant) malignancy (except non-melanomatous skin cancer or in situ cervical cancer), other than the study disease (SCCHN), unless treated with curative intent with no evidence of disease for >/= 3 years NO Prior treatment for locally advanced SSCHN NO Prior surgery for SCCHN (except nodal sampling or biopsy for study disease) NO Major surgery </= 28 days before randomization or minor surgery </= 14 days before randomization with the exception of feeding tube placement, dental extractions, central venous catheter placement, biopsies and nodal sampling

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547157

Contacts

Contact: Amgen Call Center

866-572-6436

Locations

United States, Florida
Research Site	Recruiting
Miami, Florida, United States
United States, Louisiana
Research Site	Recruiting
Alexandria, Louisiana, United States
United States, Texas
Research Site	Recruiting
Galveston, Texas, United States
Belgium
Research Site	Recruiting
Leuven, Belgium
Research Site	Recruiting
Namur, Belgium
Research Site	Completed
Gent, Belgium
Research Site	Recruiting
Liege, Belgium
Research Site	Recruiting
Charleroi, Belgium
Czech Republic
Research Site	Recruiting
Hradec Kralove, Czech Republic
Research Site	Recruiting
Praha 8_, Czech Republic
Research Site	Recruiting
Praha 5, Czech Republic
Research Site	Recruiting
Pardubice, Czech Republic
Research Site	Recruiting
Brno, Czech Republic
Mexico
Research Site	Recruiting
Puebla, Mexico
Poland
Research Site	Recruiting
Warszawa, Poland
Research Site	Recruiting
Olsztyn, Poland
Research Site	Recruiting
Gliwice, Poland
Research Site	Recruiting
Lodz, Poland
Research Site	Recruiting
Poznan, Poland
Spain
Research Site	Recruiting
Málaga, Spain
Research Site	Recruiting
Madrid, Spain
Research Site	Recruiting
Barcelona, Spain
Switzerland
Research Site	Recruiting
Aarau, Switzerland
United Kingdom
Research Site	Recruiting
Wolverhampton, United Kingdom
Research Site	Recruiting
Surrey, United Kingdom

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

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

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20062079, CONCERT2
Study First Received:	October 18, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00547157
Health Authority:	Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment; Czech Republic: State Institute for Drug Control; Mexico: COFEPRIS; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Switzerland: Swissmedic (Swiss Agency for Therapeutic Products); United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by Amgen:

head and neck
squamous cell carcinoma
radiotherapy
chemoradiotherapy
panitumumab
locally advanced head & neck cancer

EGFr
epidermal growth factor receptor
SCCHN
locally advanced SCCHN
HNC
epidermal growth factor

Study placed in the following topic categories:

Epidermoid carcinoma
Cisplatin
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell

Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Radiation-Sensitizing Agents

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009