Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046839
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2002-10-03
Brief Title:
Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Trial of a COX-2 Inhibitor Celebrex Celecoxib National Screening Committee 719627 With Limited Field Radiation for Intermediate Prognosis Patients With Locally Advanced Non-Small Cell Lung Cancer With Analysis of Prognostic Factors
Status:
COMPLETED
Status Verified Date:
2015-11
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 Radiation therapy uses high-energy x-rays to damage tumor cells Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may make the tumor cells more sensitive to radiation therapy
PURPOSE Phase III trial to study the effectiveness of combining celecoxib with radiation therapy in treating patients who have locally advanced non-small cell lung cancer
PURPOSE Phase III trial to study the effectiveness of combining celecoxib with radiation therapy in treating patients who have locally advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and the recommended phase II dose of concurrent celecoxib and limited-field radiotherapy in intermediate-prognosis patients with locally advanced non-small cell lung cancer
Determine the efficacy and toxicity of this regimen in these patients
Determine how the predictors of mortality in the general population ie comorbid conditions functional status quality of life and psychological status influence prognosis toxicity and outcomes of therapy in patients treated with this regimen
Correlate circulating levels of vascular endothelial growth factor VEGF basic fibroblast growth factor bFGF and interleukin-8 IL8 with survival in patients treated with this regimen
Correlate circulating levels of interleukin-1 IL1 interleukin-6 IL6 and transforming growth factor-beta TGFB with pulmonary toxicity in patients treated with this regimen
OUTLINE This is a phase I dose-escalation study of celecoxib followed by a phase II multicenter study
Phase I Patients receive oral celecoxib twice daily Beginning on day 6 patients undergo thoracic radiotherapy 5 days a week for 3-65 weeks Patients continue to receive celecoxib for up to 2 years in the absence of disease progression or unacceptable toxicity
Phase II If fewer than 3 of the first 6 patients experience dose-limiting toxicity then the dose of celecoxib is escalated for all patients in the study including those in the first cohort
Quality of life is assessed at baseline and at 3 6 and 12 months after start of therapy
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 6-12 patients will be accrued for the phase I portion of this study and a total of 116 patients will be accrued for the phase II portion of this study within 25 months
Determine the maximum tolerated dose and the recommended phase II dose of concurrent celecoxib and limited-field radiotherapy in intermediate-prognosis patients with locally advanced non-small cell lung cancer
Determine the efficacy and toxicity of this regimen in these patients
Determine how the predictors of mortality in the general population ie comorbid conditions functional status quality of life and psychological status influence prognosis toxicity and outcomes of therapy in patients treated with this regimen
Correlate circulating levels of vascular endothelial growth factor VEGF basic fibroblast growth factor bFGF and interleukin-8 IL8 with survival in patients treated with this regimen
Correlate circulating levels of interleukin-1 IL1 interleukin-6 IL6 and transforming growth factor-beta TGFB with pulmonary toxicity in patients treated with this regimen
OUTLINE This is a phase I dose-escalation study of celecoxib followed by a phase II multicenter study
Phase I Patients receive oral celecoxib twice daily Beginning on day 6 patients undergo thoracic radiotherapy 5 days a week for 3-65 weeks Patients continue to receive celecoxib for up to 2 years in the absence of disease progression or unacceptable toxicity
Phase II If fewer than 3 of the first 6 patients experience dose-limiting toxicity then the dose of celecoxib is escalated for all patients in the study including those in the first cohort
Quality of life is assessed at baseline and at 3 6 and 12 months after start of therapy
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 6-12 patients will be accrued for the phase I portion of this study and a total of 116 patients will be accrued for the phase II portion of this study within 25 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 |
|---|---|---|---|
| CDR0000069476 | None | None | None |