Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030407
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2002-02-14
Brief Title:
Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Evaluation Of Celecoxib In Combination With Weekly Docetaxel In Elderly 70 Years Or Poor Performance Patients With Advanced Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2013-04
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 Celecoxib may slow the growth of cancer by stopping blood flow to the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy and celecoxib may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of celecoxib and docetaxel in treating patients who have non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of celecoxib and docetaxel in treating patients who have non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the efficacy and feasibility of celecoxib combined with docetaxel as first-line therapy in elderly or poor performance status patients with advanced non-small cell lung cancer
Determine the response rate of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral celecoxib twice daily beginning on day -7 of the first course and docetaxel IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 2 additional courses after CR Patients who achieve stable disease SD or a partial response PR receive a minimum of 2 additional courses after SD or PR At the discretion of the treating physician patients then receive maintenance therapy comprising celecoxib only
Patients who discontinue therapy for disease progression or unacceptable toxicity are followed for at least 6 months
PROJECTED ACCRUAL A total of 21-39 patients will be accrued for this study within 13-28 months
Determine the efficacy and feasibility of celecoxib combined with docetaxel as first-line therapy in elderly or poor performance status patients with advanced non-small cell lung cancer
Determine the response rate of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral celecoxib twice daily beginning on day -7 of the first course and docetaxel IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 2 additional courses after CR Patients who achieve stable disease SD or a partial response PR receive a minimum of 2 additional courses after SD or PR At the discretion of the treating physician patients then receive maintenance therapy comprising celecoxib only
Patients who discontinue therapy for disease progression or unacceptable toxicity are followed for at least 6 months
PROJECTED ACCRUAL A total of 21-39 patients will be accrued for this study within 13-28 months
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 |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-C-2305 | OTHER | None | None |
| NCI-V01-1687 | Other Identifier | Barbara Ann Karmanos Cancer Institute | httpsreporternihgovquickSearchP30CA022453 |