Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00073866
Last Updated: 2012-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
INTERVENTIONAL
2003-06-30
2004-12-31
Brief Summary
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PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan and docetaxel when given together with celecoxib and to see how well they work in treating patients with advanced non-small cell lung cancer.
Detailed Description
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* Determine the recommended phase II dose of docetaxel and irinotecan in combination with celecoxib in patients with advanced non-small cell lung cancer.
* Determine the toxic effects of this regimen in these patients.
* Determine the response rate of patients treated with this regimen.
* Determine the progression-free and overall survival of patients treated with this regimen.
* Determine the pharmacokinetics of this regimen in these patients.
* Correlate angiogenesis markers (intratumoral microvessel density and vascular endothelial growth factor \[VEGF\] expression and serum VEGF) and cyclooxygenase-2 expression with response and survival in patients treated with this regimen.
* Correlate UGT1A1 genotype and CYP3A4 activity with the toxic effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study of docetaxel and irinotecan.
* Phase I: Patients receive docetaxel IV over 60 minutes and irinotecan IV over 30 minutes on days 1 and 8. Patients also receive oral celecoxib twice daily beginning on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of docetaxel and irinotecan until the recommended phase II dose is determined. The recommended phase II dose is defined as the highest dose at which 0 of 3 or 1 of 6 patients experience dose-limiting toxicity.
* Phase II: Patients receive treatment as in phase I at the recommended phase II dose.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 3-70 patients (3-36 for phase I and 16-34 for phase II) will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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celecoxib
docetaxel
irinotecan hydrochloride
Eligibility Criteria
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Inclusion Criteria
* At least 1 year since prior adjuvant or neoadjuvant chemotherapy for stage I-IIIA disease
* No prior chemotherapy for recurrent/metastatic disease
Endocrine therapy
* Less than 2 weeks of cumulative oral/IV corticosteroid use within the past 3 months
Radiotherapy
* See Disease Characteristics
* Recovered from prior radiotherapy
* At least 3 weeks since prior extensive-field radiotherapy for recurrent/metastatic disease
Surgery
* Recovered from prior surgery
Other
* More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis
* No prior NSAIDs at a frequency of more than 3 times per week for a cumulative period of more than 2 weeks within the past 30 days
* No concurrent antiepileptics, cyclosporine, aspirin, or fluconazole
* No concurrent NSAIDs
* No other concurrent COX-2 inhibitors
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
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Principal Investigators
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Athanassios Argiris, MD
Role: STUDY_CHAIR
Robert H. Lurie Cancer Center
Locations
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Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States
Silver Cross Hospital
Joliet, Illinois, United States
Countries
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References
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Argiris A, Kut V, Luong L, Avram MJ. Phase I and pharmacokinetic study of docetaxel, irinotecan, and celecoxib in patients with advanced non-small cell lung cancer. Invest New Drugs. 2006 May;24(3):203-12. doi: 10.1007/s10637-005-3259-4.
Other Identifiers
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NU-01L2
Identifier Type: -
Identifier Source: secondary_id
PHARMACIA-NU-01L2
Identifier Type: -
Identifier Source: secondary_id
NU 01L2
Identifier Type: -
Identifier Source: org_study_id