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

Alternate Title

Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 50 and under or 75 and over NCI SWOG-S0322 S0322, NCT00068497

Objectives

1. Determine the feasibility of a structured pilot study that includes pharmacokinetic sampling in patients age 75 and over or age 50 and under with metastatic or unresectable head and neck cancer or non-small lung cancer treated with gefitinib.
2. Compare, preliminarily, the peak concentration level, elimination half-life, and steady state level of gefitinib between patients in these two age groups.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed head and neck carcinoma or non-small cell lung cancer
  • Metastatic or unresectable disease for which standard curative or palliative treatment measures do not exist or are no longer effective



• Brain metastases allowed provided the metastases have been treated and are stable

Prior/Concurrent Therapy:

Biologic therapy

• No prior epidermal growth factor receptor inhibitors
• No concurrent immunotherapy for the malignancy

Chemotherapy

• Prior chemotherapy allowed
• No concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy

Radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• No concurrent agents that induce CYP3A4, including the following:
  • Nafcillin
  • Rifampin
  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • Oxcarbazepine
  • Fosphenytoin
  • Primidone
  • Hypericum perforatum (St. John's wort)
  • Rifabutin
  • Rifapentine
  • Modafinil
• No concurrent retroviral therapies for HIV-positive patients
• Recovered from prior therapy

Patient Characteristics:

Age

• 50 and under or 75 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• Bilirubin normal
• SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)

Renal

• Creatinine normal

Cardiovascular

• No severe unstable or uncompensated cardiac disease

Pulmonary

• No severe unstable or uncompensated respiratory disease

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other concurrent severe or uncontrolled systemic disease or infection
• Able to swallow oral medication in pill form

Expected Enrollment

A total of 40 patients (20 per stratum) will be accrued for this study.

Outline

This is a pilot, multicenter study. Patients are stratified according to age (75 years and over vs 50 years and under)

Patients receive oral gefitinib on day 1 and then daily beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed for 30 days and then for up to 3 years after study registration.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Manuel Valdivieso, MD, MS, CPE, Protocol co-chair		Ph: 313-576-8624; 800-527-6266 Email: valdivie@karmanos.org
Shirish Gadgeel, MD, Study coordinator		Ph: 313-576-8753; 800-527-6266 Email: gadgeels@karmanos.org

Registry Information
Official Title		Single Agent ZD-1839 in Patients with Advanced Head and Neck Carcinoma or Non-Small Cell Lung Cancer Aged 75 Years and Older (and in a Cohort of Patients 50 Years Old and Younger)
Trial Start Date		2003-08-15
Registered in ClinicalTrials.gov		NCT00068497
Date Submitted to PDQ		2003-07-23
Information Last Verified		2004-09-09
NCI Grant/Contract Number		U10-CA32102

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