Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062270
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2003-06-05
Brief Title:
Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Neoadjuvant Chemoradiotherapy GemcitabineCisplatin and Taxotere With or Without Co-Administration of ZD 1839 Iressa for Stage IIIA N2 and Selective Stage IIIB Non-Small Cell Lung Cancer Phase I-II Study
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor Combining chemotherapy and radiation therapy with gefitinib before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Phase III trial to compare the effectiveness of neoadjuvant chemoradiotherapy with or without gefitinib in treating patients who are undergoing surgery for stage III non-small cell lung cancer
PURPOSE Phase III trial to compare the effectiveness of neoadjuvant chemoradiotherapy with or without gefitinib in treating patients who are undergoing surgery for stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES Phase I
Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer
Phase II
Compare the pathologic response complete response and rate of downstaging in patients treated with neoadjuvant chemoradiotherapy with vs without gefitinib
Compare the feasibility and toxicity profile of these regimens in these patients
Compare the resection rates time to progression and overall survival of patients treated with these regimens
Correlate the percent decline in the fludeoxyglucose F 18 standardized uptake value as measured by position emission tomography with pathologic response at resection time to progression and overall survival in patients treated with these regimens
OUTLINE
Phase I This is an open-label nonrandomized study
Induction Patients receive cisplatin IV over 60 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity
Consolidation Within 3-4 weeks after the completion of induction therapy patients undergo radiotherapy once daily 5 days a week for 5 weeks and receive oral gefitinib once daily concurrently
A cohort of 3-6 patients receives consolidation chemoradiotherapy If 2 of 6 patients experience dose-limiting toxicity gefitinib is deleted from consolidation therapy in phase II arm II
Surgery Patients without disease progression after consolidation therapy undergo thoracotomy within 3-5 weeks after consolidation
Maintenance Beginning 2-4 weeks after surgery patients receive oral gefitinib once daily for 6 months in the absence of disease progression
Phase II This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive induction and consolidation therapy with the exception of gefitinib as in phase I Patients also receive docetaxel IV over 60 minutes concurrently with radiotherapy during consolidation Patients undergo surgery as in phase I
Arm II Patients receive therapy including gefitinib as in phase I Patients also receive docetaxel IV over 60 minutes concurrently with radiotherapy during consolidation
Patients are followed every 6-8 weeks for the first 12 months and then every 4-6 months thereafter
PROJECTED ACCRUAL A total of 43-80 patients 3-6 patients for phase I and 40-74 patients 20-37 per treatment arm for phase II will be accrued for this study
Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer
Phase II
Compare the pathologic response complete response and rate of downstaging in patients treated with neoadjuvant chemoradiotherapy with vs without gefitinib
Compare the feasibility and toxicity profile of these regimens in these patients
Compare the resection rates time to progression and overall survival of patients treated with these regimens
Correlate the percent decline in the fludeoxyglucose F 18 standardized uptake value as measured by position emission tomography with pathologic response at resection time to progression and overall survival in patients treated with these regimens
OUTLINE
Phase I This is an open-label nonrandomized study
Induction Patients receive cisplatin IV over 60 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity
Consolidation Within 3-4 weeks after the completion of induction therapy patients undergo radiotherapy once daily 5 days a week for 5 weeks and receive oral gefitinib once daily concurrently
A cohort of 3-6 patients receives consolidation chemoradiotherapy If 2 of 6 patients experience dose-limiting toxicity gefitinib is deleted from consolidation therapy in phase II arm II
Surgery Patients without disease progression after consolidation therapy undergo thoracotomy within 3-5 weeks after consolidation
Maintenance Beginning 2-4 weeks after surgery patients receive oral gefitinib once daily for 6 months in the absence of disease progression
Phase II This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive induction and consolidation therapy with the exception of gefitinib as in phase I Patients also receive docetaxel IV over 60 minutes concurrently with radiotherapy during consolidation Patients undergo surgery as in phase I
Arm II Patients receive therapy including gefitinib as in phase I Patients also receive docetaxel IV over 60 minutes concurrently with radiotherapy during consolidation
Patients are followed every 6-8 weeks for the first 12 months and then every 4-6 months thereafter
PROJECTED ACCRUAL A total of 43-80 patients 3-6 patients for phase I and 40-74 patients 20-37 per treatment arm for phase II 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 |
|---|---|---|---|
| AVENTIS-GIA-12139 | None | None | None |
| UAB-0162 | None | None | None |
| UAB-F020730006 | None | None | None |
| ZENECA-ZD1839US-0207 | None | None | None |