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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00268255
Recruitment Status : Withdrawn (Study never moved forward with accrual.)
First Posted : December 22, 2005
Last Update Posted : April 16, 2013
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Brief Summary:

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 or disease Intervention/treatment 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 1 Phase 2

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


Performance status

  • Any performance status

Life expectancy

  • At least 1 year


  • No restrictions


  • No restrictions


  • Creatinine ≤ CTC grade 2


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


  • 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



  • No prior chemotherapy


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


  • Recovered from prior surgery
  • No concurrent ophthalmic surgery


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00268255

Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Study Chair: Andrew T. Turrisi, MD Barbara Ann Karmanos Cancer Institute

Responsible Party: Barbara Ann Karmanos Cancer Institute Identifier: NCT00268255     History of Changes
Other Study ID Numbers: CDR0000447160
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: April 16, 2013
Last Verified: April 2013

Keywords provided by Barbara Ann Karmanos Cancer Institute:
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Enzyme Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action