Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062101
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
2003-06-05
Brief Title:
Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of OSI 774 IND Number 63383 in Combination With Celecoxib Celebrex Pharmacia as Second-Line Therapy in Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase II trial is studying how well giving erlotinib together with celecoxib works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Celecoxib may slow the growth of a tumor by stopping blood flow to the tumor Combining erlotinib with celecoxib may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate of patients with stage IIIB or IV recurrent non-small cell lung cancer treated with erlotinib and celecoxib as second-line therapy
SECONDARY OBJECTIVES
I Determine the time to progression in patients treated with this regimen II Determine the survival duration of patients treated with this regimen III Determine the toxicity of this regimen in these patients IV Correlate the expression of epidermal growth factor receptor and cyclooxygenase-2 in tumor specimens with response time to progression and survival in patients treated with this regimen
OUTLINE Patients are assigned to 1 of 2 treatment groups
Group 1 Patients receive oral erlotinib once daily and oral celecoxib twice daily
Group 2 Patients receive erlotinib as in group 1
Treatment in both groups continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 40-80 patients will be accrued for this study within 10 months
I Determine the response rate of patients with stage IIIB or IV recurrent non-small cell lung cancer treated with erlotinib and celecoxib as second-line therapy
SECONDARY OBJECTIVES
I Determine the time to progression in patients treated with this regimen II Determine the survival duration of patients treated with this regimen III Determine the toxicity of this regimen in these patients IV Correlate the expression of epidermal growth factor receptor and cyclooxygenase-2 in tumor specimens with response time to progression and survival in patients treated with this regimen
OUTLINE Patients are assigned to 1 of 2 treatment groups
Group 1 Patients receive oral erlotinib once daily and oral celecoxib twice daily
Group 2 Patients receive erlotinib as in group 1
Treatment in both groups continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 40-80 patients will be accrued for this study within 10 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 |
|---|---|---|---|
| CDR0000304495 | None | None | None |
| LUNG 2002-01 | None | None | None |
| NCI-5416 | None | None | None |