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

NCT ID: NCT00015964

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2005-07-31

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer

Keywords

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recurrent metastatic squamous neck cancer with occult primary metastatic squamous neck cancer with occult primary squamous cell carcinoma stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daily administration of ZD1839

Group Type EXPERIMENTAL

ZD1839

Intervention Type DRUG

Interventions

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ZD1839

Intervention Type DRUG

Other Intervention Names

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gefitinib, Iressa ®

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck that is incurable by surgery or radiotherapy At least 1 lesion measurable in at least 1 dimension At least 20 mm by conventional techniques OR At least 10 mm by CT scan No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100% Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reactions to compounds of similar chemical or biological composition to ZD 1839 No active infection No other uncontrolled illness No psychiatric illness or social situation that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior epidermal growth factor receptor-based therapy for recurrent disease Chemotherapy: No more than 1 prior adjuvant or neoadjuvant chemotherapy and/or chemoradiotherapy regimen At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics See Chemotherapy At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: No more than 1 prior regimen for recurrent disease No other concurrent investigational agents No concurrent combination antiretroviral therapy for HIV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Everett Vokes, MD

Role: STUDY_CHAIR

University of Chicago

Locations

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University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

Louis A. Weiss Memorial Hospital

Chicago, Illinois, United States

Site Status

Cancer Care Specialists of Central Illinois, S.C.

Decatur, Illinois, United States

Site Status

Evanston Northwestern Health Care

Evanston, Illinois, United States

Site Status

Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status

Columbia LaGrange Memorial Hospital

LaGrange, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

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

Peoria, Illinois, United States

Site Status

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, United States

Site Status

Michiana Hematology/Oncology P.C.

South Bend, Indiana, United States

Site Status

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

Saint Joseph, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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UCCRC-10869

Identifier Type: -

Identifier Source: secondary_id

NCI-1721

Identifier Type: -

Identifier Source: secondary_id

10869A

Identifier Type: -

Identifier Source: org_study_id