Phase 2 N=152 Randomized Treatment

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

Cancer · Head and Neck Cancer · Oncology · Squamous Cell Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT00547157 ↗

Enrolled (actual)

152

Serious AEs

36.4%

Results posted

May 2014

Primary outcome: Primary: Local Regional Control Rate at 2 Years — 0.51; 0.61 Proportion of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Panitumumab (Drug); Cisplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Local Regional Control Rate at 2 Years	0.51; 0.61	—
SECONDARY Duration of Local Regional Control	25.1; NA	0.0601
SECONDARY Progression-free Survival	17.3; NA	0.0259 sig
SECONDARY Overall Survival	41.7; NA	0.1039
SECONDARY ORR by 6 Months - Central	0.722; 0.767	0.5744
SECONDARY CRR by 6 Months - Central	0.144; 0.117	0.8070

Summary

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT00547157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.