Spots Global Cancer Trial Database for Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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