Celecoxib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Tracking Information | |||||
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First Received Date ICMJE | March 3, 2005 | ||||
Last Updated Date | August 2, 2012 | ||||
Start Date ICMJE | December 2004 | ||||
Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week | ||||
Change History | Complete list of historical versions of study NCT00104767 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Celecoxib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer | ||||
Official Title ICMJE | A Phase I Trial to Evaluate Cyclooxygenase 2 Inhibitor-Mediated Modulation of T Regulatory Cells in Advanced Non-Small Cell Lung Cancer (NSCLC) | ||||
Brief Summary | RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib in treating patients with stage IIIB or stage IV non-small cell lung cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a nonrandomized, dose-escalation study. Patients receive oral celecoxib twice daily on days 1-7 in the absence of unacceptable toxicity. Cohorts of 3 patients receive escalating doses of celecoxib until the optimal biologic dose (OBD) is determined. The OBD is defined as the lowest dose that results in the maximum decrease in peripheral blood lymphocyte CD4+ and CD25+ T-lymphocyte regulatory cells and FOXP3 levels where no dose-limiting toxicity occurs. An additional 15 patients are treated at the OBD. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Lung Cancer | ||||
Intervention ICMJE | Drug: celecoxib | ||||
Study Arm (s) | Experimental: celecoxib
Intervention: Drug: celecoxib |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 24 | ||||
Completion Date | |||||
Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | |||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00104767 | ||||
Other Study ID Numbers ICMJE | CDR0000415733, UCLA-0407028-01 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Jonsson Comprehensive Cancer Center | ||||
Study Sponsor ICMJE | Jonsson Comprehensive Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | Jonsson Comprehensive Cancer Center | ||||
Verification Date | August 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |