Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI UUMC-8429-01 NCI-1701, NCT00024089, 1701

Objectives

1. Determine the disease control rate, in terms of complete response, partial response, and stable disease for at least 4 months, in patients with recurrent and/or metastatic squamous cell cancer of the head and neck treated with gefitinib.
2. Determine the effect of this drug on epidermal growth factor receptor phosphorylation and expression of selected genes in these patients.
3. Determine the toxic effects of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed primary squamous cell cancer of the head and neck that is incurable by surgery or radiotherapy
  • Stratum I:
    • Failed surgery and/or radiotherapy and received no prior systemic chemotherapy for recurrent disease

      OR

    • Recurrent disease at least 6 months after prior multimodal primary therapy including neoadjuvant or concurrent chemotherapy

      OR

    • Metastatic disease at initial diagnosis and received no prior chemotherapy
  • Stratum II:
    • No more than 1 prior chemotherapy regimen for recurrent disease

      OR

    • Recurrent disease within 6 months after prior primary therapy that included chemotherapy



• Measurable disease
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Clear clinical evidence of progression or biopsy-proven residual cancer required if only site of measurable disease is in a previously irradiated field



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy:

• No prior therapy with agents that target epidermal growth factor receptors

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

• No concurrent tamoxifen

Radiotherapy:

• See Disease Characteristics
• Prior radiotherapy as primary or secondary treatment allowed
• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics
• Prior surgery as primary or secondary treatment allowed
• At least 4 weeks since prior major surgery

Other:

• No other concurrent investigational agents
• No concurrent combination antiretroviral therapy for HIV
• No concurrent 3A4 inhibitors (e.g., ketoconazole, erythromycin, verapamil)
• No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, amiodarone, chloroquine)

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

  OR

• 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 (no greater than 1.5 times upper limit of normal [ULN] if liver metastases present)
• AST/ALT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other:

• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other uncontrolled concurrent illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No prior allergic reactions attributed to compounds of similar chemical or biologic composition to gefitinib
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 50-60 patients (25-30 per stratum) will be accrued for this study within 2 years.

Outcomes

Disease control rate

Biologic parameters
Toxicity
Response

Outline

Patients are stratified as delineated in the Disease Characteristics.

Patients receive oral gefitinib daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Trial Contact Information

Trial Lead Organizations

Huntsman Cancer Institute at University of Utah

Richard Wheeler, MD, Protocol chair(Contact information may not be current)		Ph: 801-585-0303; 877-585-0303

Registry Information
Official Title		A Phase II Study of ZD 1839 (Iressa) in Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck
Trial Start Date		2001-07-02
Trial Completion Date		2006-03-10
Registered in ClinicalTrials.gov		NCT00024089
Date Submitted to PDQ		2001-07-17
Information Last Verified		2005-11-07
NCI Grant/Contract Number		P30-CA42014

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