Clinical Trials Directory

Trials / Completed

CompletedNCT00114283

Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

A Phase 2 Trial of GW572016 in Patients With Metastatic and Recurrent Squamous Cell Carcinomas of the Head and Neck

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well lapatinib ditosylate works in treating patients with metastatic or recurrent head and neck cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. The primary objective of this study is to estimate the objective response rate (complete response \[CR\] + partial response \[PR\]) in patients with squamous cell carcinomas of the head and neck following treatment with GW572016 (lapatinib ditosylate). SECONDARY OBJECTIVES: I. Secondary objectives of this study are to estimate time to progression, describe the adverse event profile, and to obtain preliminary assessments of changes in pre- versus post-treatment measurements for selected biomarkers in tumor cells from these patients. OUTLINE: Patients receive lapatinib ditosylate orally (PO) once daily (QD). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year.

Conditions

Interventions

TypeNameDescription
DRUGlapatinib ditosylateGiven PO
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2005-03-01
Primary completion
2006-10-01
Completion
2006-10-01
First posted
2005-06-14
Last updated
2015-04-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00114283. Inclusion in this directory is not an endorsement.