South Bend, Indiana 46617

  • Head and Neck Cancer


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.

Study summary:

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.


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 is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

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

Official Title:

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

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Chicago

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Endpoint Classification: Efficacy Study, Interven

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Everett Vokes, MD
Study Chair
University of Chicago

Study Dates

Start Date:March 2001
Completion Date:July 2005
Completion Type:Actual
Primary Completion Date:September 2001
Primary Completion Type:Actual
Verification Date:September 2013
Last Changed Date:September 4, 2013
First Received Date:May 6, 2001

Study Outcomes

Outcome Type:Primary Outcome
Measure:Early response rates of ZD1839 in head and neck tumors
Time Frame:2 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Arm Name:Daily administration of ZD1839
Other Name:gefitinib, Iressa ®

Study Arms

Study Arm Type:Experimental
Arm Name:Daily administration of ZD1839

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Chicago
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: March 30, 2020

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