RATIONALE: Biological therapies such as ZD1839 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.

Condition	Treatment or Intervention	Phase
Nose Cancer Oral Cancer Throat Cancer	Drug: ZD 1839	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Illinois
      Cancer Care Specialists of Central Illinois, S.C., Decatur,  Illinois,  62526,  United States
      Columbia LaGrange Memorial Hospital, LaGrange,  Illinois,  60525,  United States
      Evanston Northwestern Health Care, Evanston,  Illinois,  60201,  United States
      Ingalls Memorial Hospital, Harvey,  Illinois,  60426,  United States
      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States
      Oncology/Hematology Associates of Central Illinois, P.C., Peoria,  Illinois,  61602,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States
Indiana
      Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne,  Indiana,  46885-5099,  United States
      Michiana Hematology/Oncology P.C., South Bend,  Indiana,  46617,  United States
Michigan
      Oncology Care Associates, P.L.L.C., Saint Joseph,  Michigan,  49085,  United States

Study chairs or principal investigators

Fred R. Rosen,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000068577; UCCRC-10869; NCI-1721; UCCRC-NCI-1721
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  May 6, 2001
ClinicalTrials.gov Identifier:  NCT00015964
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08