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

Non-small Cell Lung Cancer Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

• NCT number: NCT00268255
• Study type: Interventional
• Source: Barbara Ann Karmanos Cancer Institute
• Status: Withdrawn
• Phase: Phase 1/Phase 2