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ZD 1839 in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck

Phase 2
Completed
Conditions
Head and Neck Cancer
Interventions
Registration Number
NCT00015964
Lead Sponsor
University of Chicago
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
51
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Daily administration of ZD1839ZD1839-
Primary Outcome Measures
NameTimeMethod
Early response rates of ZD1839 in head and neck tumors2 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

Evanston Northwestern Health Care

🇺🇸

Evanston, Illinois, United States

University of Chicago Cancer Research Center

🇺🇸

Chicago, Illinois, United States

Louis A. Weiss Memorial Hospital

🇺🇸

Chicago, Illinois, United States

Cancer Care Specialists of Central Illinois, S.C.

🇺🇸

Decatur, Illinois, United States

Loyola University Medical Center

🇺🇸

Maywood, Illinois, United States

Fort Wayne Medical Oncology and Hematology, Inc.

🇺🇸

Fort Wayne, Indiana, United States

Michiana Hematology/Oncology P.C.

🇺🇸

South Bend, Indiana, United States

Columbia LaGrange Memorial Hospital

🇺🇸

LaGrange, Illinois, United States

Ingalls Memorial Hospital

🇺🇸

Harvey, Illinois, United States

Oncology/Hematology Associates of Central Illinois, P.C.

🇺🇸

Peoria, Illinois, United States

Oncology Care Associates, P.L.L.C.

🇺🇸

Saint Joseph, Michigan, United States

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