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NCT00015964 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00015964
Other study ID # 10869A
Secondary ID UCCRC-10869NCI-1
Status Completed
Phase Phase 2
First received May 6, 2001
Last updated September 4, 2013
Start date March 2001
Est. completion date July 2005

Study information
Verified date September 2013
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 51
Est. completion date July 2005
Est. primary completion date September 2001
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ZD1839

Locations
Country Name City State
United States Louis A. Weiss Memorial Hospital Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States Cancer Care Specialists of Central Illinois, S.C. Decatur Illinois
United States Evanston Northwestern Health Care Evanston Illinois
United States Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne Indiana
United States Ingalls Memorial Hospital Harvey Illinois
United States Columbia LaGrange Memorial Hospital LaGrange Illinois
United States Loyola University Medical Center Maywood 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 Michiana Hematology/Oncology P.C. South Bend Indiana

Sponsors (2)
Lead Sponsor Collaborator
University of Chicago National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Early response rates of ZD1839 in head and neck tumors 2 months No
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