A Phase 2, Randomized Trial of Chemoradiation with or withoutPanitumumab in Subjects with Unresected, Locally Advanced Squamous CellCarcinoma of the Head and Neck

Amgen Inc0 sites246 target enrollmentSeptember 4, 2007

Overview

No summary available.

Registry

who.int

Start Date

September 4, 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Inclusion Criteria
•Disease\-Related:
•Histologically or cytologically confirmed SCC of oral cavity, oropharynx, hypopharynx, or larynx.
•Subjects requiring prophylactic tracheostomy.
•Stage III or Stage IVa\-b (M0\) disease according to the American Joint Committee on •Cancer staging manual 6th edition.
•ECOG performance status of 0 or 1 (refer to Appendix H).
•Bidimensionally measurable disease \= 10 mm in at least 1 dimension.
•Demographic:
•Man or woman \= 18 years of age.
•Laboratory:

•Exclusion Criteria
•Disease Related:
•Primary tumor of the nasopharynx, sinuses, salivary gland, or skin.
•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
•Medications or Radiotherapy:
•Prior anti\-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule tyrosine kinase inhibitors of EGFr (eg, gefitinib, erlotinib, lapatinib).
•Prior surgery for SCCHN (except nodal sampling or biopsy for study disease).
•Prior radiotherapy in the planned field.
•Prior systemic chemotherapy for the study cancer.
•Major surgery \= 28 days before randomization or minor surgery \= 14 days before randomization with the exception that feeding tube placement, dental extractions, central venous catheter placement, biopsies (endoscopic or otherwise), and nodal sampling are allowed at any time prior to randomization.