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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Amgen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00547157
First received: October 18, 2007
Last updated: January 20, 2011
Last verified: January 2011

October 18, 2007
January 20, 2011
November 2007
October 2011   (final data collection date for primary outcome measure)
Efficacy: LRC rate at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Efficacy: LRC rate at 2 years
Complete list of historical versions of study NCT00547157 on ClinicalTrials.gov Archive Site
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 ]
Efficacy: PFS, OS, duration of LRC, LRC at 6 months and 1 year, rate of CR by 6 months, ORR by 6 months, Safety
Not Provided
Not Provided
 
Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Head and Neck Cancer
  • Oncology
  • Squamous Cell Carcinoma
  • Drug: Panitumumab
    Arm 2 consists of panitmumab plus RT
    Other Name: Panitumumab (drug)
  • Drug: Cisplatin
    Cisplatin
  • Active Comparator: ARM 1 CRT
    Cisplatin plus RT
    Intervention: Drug: Cisplatin
  • Experimental: ARM 2 PRT
    Panitumumab plus RT
    Intervention: Drug: Panitumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
December 2011
October 2011   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00547157
20062079, CONCERT2
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP