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

Tracking Information

First Received Date ^ICMJE

September 10, 2003

Last Updated Date

February 14, 2009

Start Date ^ICMJE

August 2003

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00068497 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief Summary

RATIONALE: Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase I trial is studying the side effects of gefitinib in treating patients with metastatic or unresectable head and neck cancer or non-small cell lung cancer.

Detailed Description

OBJECTIVES:

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.
Compare, preliminarily, the peak concentration level, elimination half-life, and steady state level of gefitinib between patients in these two age groups.

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.

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Head and Neck Cancer
Lung Cancer

Intervention ^ICMJE

Drug: gefitinib

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

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/mm^3
Platelet count ≥ 100,000/mm^3

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

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00068497

Responsible Party

Study ID Numbers ^ICMJE

CDR0000322890, SWOG-S0322

Study Sponsor ^ICMJE

Southwest Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Investigator:	Manuel Valdivieso, MD, MS, CPE	Barbara Ann Karmanos Cancer Institute
Investigator:	Shirish M. Gadgeel, MD	Barbara Ann Karmanos Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP