Clinical Trial: Lapatinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study Of GW572016 In Squamous Cell Carcinoma Of The Head And Neck (SCCHN)

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 Summary:

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.

Current Primary Outcome:

• Objective response rate by RECIST [ Time Frame: Up to 6 years ]
  The 95% confidence intervals should be provided.
• Progression-free survival (PFS) [ Time Frame: From start of treatment to time of disease progression, assessed up to 6 years ]
  Will be estimated using the Kaplan-Meier method.

Original Primary Outcome:

Current Secondary Outcome:

• Overall survival [ Time Frame: Up to 6 years ]
  Will be estimated using the Kaplan-Meier method.
• Changes in EGFR, pEGFR, HER2 [ Time Frame: Baseline and 12 weeks ]
  Paired t-tests or Wilcoxon signed rank tests will be performed to examine the magnitude and significance of pre-post treatment changes. To determine whether these markers are correlated with tumor response, both the baseline levels and the pre-post changes will be compared between responders and non-responders using the nonparametric, Wilcoxon rank-sum test. The correlative data will also be entered as covariates into a Cox regression model to determine whether they are predictive of progression-free and overall survival.
• Adverse events assessed using NCI CTCAE version 3.0 [ Time Frame: Up to 6 years ]
  Adverse events will be summarized by type and grade.

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: December 7, 2004
Date Started: October 2004
Date Completion:
Last Updated: January 6, 2014
Last Verified: January 2014