Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062179
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2003-06-05
Brief Title:
Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Randomized Double Blind Phase II Study of Preoperative CelecoxibPaclitaxelCarboplatin for Stage IIIA Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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 such as paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug may stop the growth of tumor cells by stopping blood flow to the tumor andor may block the enzymes necessary for tumor cell growth Giving combination chemotherapy with celecoxib before surgery may kill more tumor cells
PURPOSE This randomized phase II trial is studying how well giving paclitaxel together with carboplatin followed by surgery works compared to giving paclitaxel together with carboplatin and celecoxib followed by surgery in treating patients with stage IIIA non-small cell lung cancer
PURPOSE This randomized phase II trial is studying how well giving paclitaxel together with carboplatin followed by surgery works compared to giving paclitaxel together with carboplatin and celecoxib followed by surgery in treating patients with stage IIIA non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the complete pathological response rate andor minimal residual microscopic disease in patients with stage IIIA non-small cell lung cancer treated with preoperative paclitaxel and carboplatin with vs without celecoxib
Compare the clinical response rate in patients treated with these regimens
Compare chemotherapy-related toxicity in patients treated with these regimens
Compare the time to progression disease-free survival and overall survival of patients treated with these regimens
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to use of aspirin for prior cardiovascular disease yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1 22 and 43 Patients also receive oral celecoxib twice daily beginning on day 1 and continuing until the morning of surgical resection
Arm II Patients receive paclitaxel and carboplatin as in arm I and an oral placebo twice daily beginning on day 1 and continuing until the morning of surgical resection
In both arms patients undergo surgical resection and complete mediastinal lymph node dissection within 3-6 weeks after completion of chemotherapy Patients resume oral celecoxib or placebo twice daily within 28-42 days after surgery and continue until 3 years from the date of randomization in the absence of disease progression or unacceptable toxicity
Patients are followed every 3-6 months
PROJECTED ACCRUAL A total of 110 patients 55 per treatment arm will be accrued for this study
Compare the complete pathological response rate andor minimal residual microscopic disease in patients with stage IIIA non-small cell lung cancer treated with preoperative paclitaxel and carboplatin with vs without celecoxib
Compare the clinical response rate in patients treated with these regimens
Compare chemotherapy-related toxicity in patients treated with these regimens
Compare the time to progression disease-free survival and overall survival of patients treated with these regimens
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to use of aspirin for prior cardiovascular disease yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1 22 and 43 Patients also receive oral celecoxib twice daily beginning on day 1 and continuing until the morning of surgical resection
Arm II Patients receive paclitaxel and carboplatin as in arm I and an oral placebo twice daily beginning on day 1 and continuing until the morning of surgical resection
In both arms patients undergo surgical resection and complete mediastinal lymph node dissection within 3-6 weeks after completion of chemotherapy Patients resume oral celecoxib or placebo twice daily within 28-42 days after surgery and continue until 3 years from the date of randomization in the absence of disease progression or unacceptable toxicity
Patients are followed every 3-6 months
PROJECTED ACCRUAL A total of 110 patients 55 per treatment arm 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 |
|---|---|---|---|
| PHARMACIA-COXAON-0509-106 | None | None | None |
| UCLA-0208074 | None | None | None |
| NYH-CMC-0902-464 | None | None | None |