Gefitinib and Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Barbara Ann Karmanos Cancer Institute
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00268255

Purpose

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may make tumor cells more sensitive to radiation therapy. Giving gefitinib together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given together with gefitinib and to see how well they work in treating patients with inoperable stage I or stage II non-small cell lung cancer.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: gefitinib Procedure: adjuvant therapy Procedure: enzyme inhibitor therapy Procedure: neoadjuvant therapy Procedure: protein tyrosine kinase inhibitor therapy Procedure: radiation therapy Procedure: radiosensitization	Phase I Phase II

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy

Drug Information available for: Tyrosine ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I/II Study of Induction Gefitinib and Concurrent Radiotherapy in Patients With Previously Untreated, Medically Inoperable Stage I or II Non-Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Detailed Description:

OBJECTIVES:

Primary

Determine the toxicity profile and maximum tolerated dose of radiotherapy when given in combination with gefitinib in patients with previously untreated, medically inoperable stage I or II non-small cell lung cancer. (Phase I)
Determine the efficacy of gefitinib when given for 6 weeks prior to and concurrent with radiotherapy, in terms of objective response rate (partial and complete response), in these patients.

Secondary

Determine the 3-month tumor response (complete and partial response) in patients treated with this regimen.
Determine the 6-week response rate in patients treated with this regimen.
Determine the local disease control rate (complete and partial response, stable disease) in patients treated with this regimen.
Determine the local progression-free survival and disease-specific survival (cancer vs co-morbid disease) of patients treated with this regimen.
Determine the pattern of failure (e.g., local, regional, or distant metastasis) in patients treated with this regimen.
Determine the acute and late radiation toxic effects to organs at risk in patients treated with this regimen.
Determine the safety profile of gefitinib in these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study of radiotherapy.

Patients receive oral gefitinib once daily for 13 weeks. Patients also undergo radiotherapy 5 days a week for 7 weeks beginning at week 7. Patients continue to receive gefitinib alone after completion of radiotherapy in the absence of disease progression or unacceptable toxicity.

Cohorts of 6-10 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience acute dose-limiting toxicity.

Phase II: Patients receive oral gefitinib as in phase I and radiotherapy at the MTD determined in phase I. After the completion of radiotherapy, patients continue to receive gefitinib in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 1 year.

PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer (NSCLC)
Any non-small cell histology allowed
T1-3, N0* disease
No metastatic disease
Refused or ineligible for surgery
Measurable disease, defined as lesion diameter ≤ 5 cm NOTE: *No evidence of N1 or N2 disease by positron emission tomography (PET) scan or any histological means (mediastinoscopy, thoracotomy, transbronchial, tracheal aspirations, or transesophageal aspiration by endoscopic ultrasound guidance

PATIENT CHARACTERISTICS:

Performance status

Any performance status

Life expectancy

At least 1 year

Hematopoietic

No restrictions

Hepatic

No restrictions

Renal

Creatinine ≤ CTC grade 2

Pulmonary

No clinically active interstitial lung disease
Chronic, stable, asymptomatic radiographic changes allowed

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective nonhormonal contraception
No known severe hypersensitivity to gefitinib or any of the excipients of this product
No other malignancy within the past 5 years except basal cell cancer or carcinoma in situ of the cervix
No active or uncontrolled infection
No uncontrolled systemic disease
No psychiatric illness or other severe medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Chemotherapy

No prior chemotherapy

Radiotherapy

No prior radiotherapy to the chest or mediastinum
No concurrent elective nodal irradiation

Surgery

Recovered from prior surgery
No concurrent ophthalmic surgery

Other

Recovered from all other prior anticancer therapy (alopecia allowed)
More than 30 days since prior nonapproved or investigational agents
No concurrent CYP3A4 inducers, including any of the following:
Phenytoin
Carbamazepine
Barbiturates
Rifampin
Phenobarbital
Hypericum perforatum (St. John's wort)
No concurrent systemic retinoids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268255

Locations

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201

Sponsors and Collaborators

Barbara Ann Karmanos Cancer Institute

Investigators

Study Chair:

Andrew T. Turrisi, MD

Barbara Ann Karmanos Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000447160, WSU-D-2820, WSU-HIC-100304M1F, ZENECA-1839US/0258
Study First Received:	December 20, 2005
Last Updated:	December 4, 2006
ClinicalTrials.gov Identifier:	NCT00268255 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I non-small cell lung cancer
stage II non-small cell lung cancer
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer

large cell lung cancer
squamous cell lung cancer
adenocarcinoma of the lung

Study placed in the following topic categories:

Thoracic Neoplasms
Adenocarcinoma, Bronchiolo-Alveolar
Adjuvants, Immunologic
Protein Kinase Inhibitors
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Non-small Cell Lung Cancer
Adenocarcinoma of Lung
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Gefitinib
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma

Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Gefitinib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009