A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects with Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Overview

No summary available.

Registry

who.int

Start Date

November 14, 2006

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Willing and able to sign a written informed consent.
•2\. Histologically confirmed diagnosis of SCCHN of one of the following sites: oral cavity, oropharynx, hypopharynx and larynx.
•3\. Pathological Stage II, III or IVa with no evidence of gross residual diease, and at least one of the high risk factors by pathology (as listed in protocol)
•4\. Primary surgery with a curative intent completed within 4\-6 weeks (and no later than 8 weeks) prior to randomization. The extent of surgical resection is defined in the protocol.
•5\. Complete recovery from the surgical procedure. Radiation therapy is required to start as soon as adequate healing has occurred. This is normally around 4\-6 weeks but no later than 9 weeks after surgery.
•6\. Adequate tumour specimen from archived or resected tissue must be available for IHC evaluation of ErbB1 expression levels in a central laboratory and subsequent biomarker analysis.
•7\. Male or female, between 18 and 70 years of age
•Criteria for female subjects or female partners of male subjects as defined in the protocol
•9\. ECOG performance status 0, 1 or 2
•10\. Adequate haematology, renal and hepatic function , as defined in the protocol

•1\. Nasopharyngeal, paranasal sinuses or nasal cavity tumours
•2\. Head and neck cancer with histology other than squamous cell.
•3\. Evidence of distant metastases or gross post\-operative residual disease
•4\. Evidence of second primary tumor.
•5\. Any prior or current anticancer treatment of any kind – except the primary surgical resection. This will include but not exclusive to: prior tyrosine kinase inhibitors, prior neoadjuvant therapy, prior radiotherapy or use of any investigational agent.
•6\. Concurrent treatment with an investigational agent or participation in another clinical trial.
•7\. Concurrent use of CYP3A4 inducers or inhibitors while on investigational product. A standard 3\-day course of dexamethasone for the prevention of cisplatin induced nausea and vomiting is allowed.
•8\. Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
•9\. Pregnant or lactating females
•10\. History of another malignancy within the last 5 years, with the exception of completely resected basal or squamous cell skin cancer, or successfully treated in\-situ carcinoma. History of non\-invasive lesion or in\-situ carcinoma, including in the head and neck region that was successfully treated with surgery, photodynamics or laser, will be permitted;