Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268255
Status:
WITHDRAWN
Last Update Posted:
2013-04-16
First Post:
2005-12-20
Brief Title:
Gefitinib and Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase III 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WITHDRAWN
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never moved forward with accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 III 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
PURPOSE This phase III 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
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZENECA-1839US0258 | None | None | None |
| WSU-HIC-100304M1F | None | None | None |
| WSU-D-2820 | None | None | None |