A Phase II Stdy of ZD 1839 in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

University of Chicago11 sites in 1 country51 target enrollmentMarch 2001

ConditionsHead and Neck Cancer

InterventionsZD1839

DrugsZD1839

Overview

Phase: Phase 2
Intervention: ZD1839
Conditions: Head and Neck Cancer
Sponsor: University of Chicago
Enrollment: 51
Locations: 11
Primary Endpoint: Early response rates of ZD1839 in head and neck tumors
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of head and neck cancer.

PURPOSE: Phase II trial to study the effectiveness of ZD1839 in treating patients who have metastatic or recurrent cancer of the head and neck.

Detailed Description

OBJECTIVES: I. Determine the activity of ZD 1839 in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. II. Determine the effectiveness of this regimen in these patients. III. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within 1-2 years.

Registry

clinicaltrials.gov

Start Date

March 2001

End Date

July 2005

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group