drugset / Trial / NCT00490061

Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent Chemotherapy

NCT00490061 ↗

Phase 2 Terminated 17 enrolled Quynh-Thu Le GlaxoSmithKline · collab
NaSingle-groupOpen-labelTreatment

Summary

We propose to combine lapatinib with RT alone in patients with locally advanced head and neck cancer who cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in this group of patients. In addition, we will determine the 2-year locoregional control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these patients. We will also evaluate the profile and frequency of late toxicity, specifically mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

Timeline

Start
2007-07
Primary completion
2013-01
Completion
2016-06

Outcome

Outcome not reported

Stopped (Enrollment): “Poor accrual.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Lapatinib Small molecule 1500 mg Oral