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

Study Description

Brief Summary: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. This phase II trial is studying how well lapatinib works in treating patients with recurrent and/or metastatic head and neck cancer.

Detailed Description: PRIMARY OBJECTIVES: I. Determine the overall response rate in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with lapatinib. II. Determine the progression-free survival, time to progression, and overall survival of patients treated with this drug. III. Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 cohorts according to prior epidermal growth factor receptor-targeted therapy (yes vs no). Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 40-88 patients (21-50 epidermal growth factor receptor \[EGFR\] inhibitor-naive patients \[cohort A\] and 19-38 EGFR inhibitor-pre-treated patients \[cohort B\]) will be accrued for this study within 4-12.6 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial