- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00088959
Celecoxib and Erlotinib in Treating Former Smokers With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Phase I Study of Erlotinib and Celecoxib in Former Smokers With Advanced Non-Small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To estimate the clinical toxicity and tolerability of erlotinib combined with celecoxib in patients with advanced non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. To estimate the tumor response rate of erlotinib combined with celecoxib in patients with advanced NSCLC.
II. To estimate the dose of celecoxib that results in maximal induction of apoptosis, maximal inhibition of prostaglandin E2 (PGE2) in bronchoalveolar (BAL) fluid, and maximal inhibition of bronchial cell proliferation when combined with erlotinib.
III. To estimate the effect of erlotinib and the combination of erlotinib and celecoxib on bronchial expression of COX-2.
IV. To estimate the effect of erlotinib and the combination of erlotinib (and celecoxib on autophosphorylation of epidermal growth factor receptor (EGFR) in skin and endobronchial biopsies.
V. To estimate the degree of correlation of autophosphorylation of EGFR in skin and endobronchial samples.
TERTIARY OBJECTIVES:
I. To estimate the effect of the combination of erlotinib and COX-2 inhibitor (celecoxib) on the frequency of fractional allelic loss (FAL) in endobronchial biopsies, metaplasia and dysplasia in endobronchial biopsies, and endobronchial proliferation.
OUTLINE: This is an open-label, dose-escalation study of celecoxib.
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 6 additional patients are treated at the MTD.
Patients are followed at 4 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Criteria:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria: Stage IIIB with pleural effusion; Stage IV disease; recurrent or progressive disease after prior surgery, radiotherapy, and/or chemotherapy
- If the sole prior treatment was in the adjuvant or neoadjuvant setting, tumor progression or recurrence must have occurred within 6 months after completion of prior treatment
- Absolute neutrophil count >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 10 g/dL
- Hemostasis normal
- Creatinine =< 2.0 mg/dL
- No significant cardiovascular disease
- No New York Heart Association class III or IV cardiac disease
- No uncontrolled dysrhythmia
- No unstable angina
- No myocardial infarction within the past 6 months
- FEV1 >= 1.0 liter OR 40% of predicted within the past 3 months
- Oxygen saturation >= 90% on room air
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study treatment
- Willing to undergo bronchoscopy
- No allergy to sulfonamides or hypersensitivity reaction to celecoxib
- No other medical or psychological condition (e.g., acute psychosis) that would preclude study participation
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin)
- At least 4 weeks since prior radiotherapy
- Prior complete resection allowed provided there is histologic and cytologic documentation of disease recurrence
- More than 3 months since prior chemopreventative agents (e.g., oltipraz, retinoids, or N-acetylcysteine [NAC])
- No prior erlotinib hydrochloride
- No other prior EGFR antagonists
- No concurrent medication known to interact with erlotinib hydrochloride or celecoxib, including the following: Fluconazole, Lithium, Furosemide, Angiotensin-converting enzyme inhibitors, Phenytoin, Carbamazepine, Rifampin, Barbiturates, Hypericum perforatum (St. John's wort)
- No concurrent non-steroidal anti-inflammatory drugs
- Concurrent aspirin of up to an average dose of 325 mg/day allowed
- No aspirin treatment for 7 days prior to any bronchoscopic or skin biopsy
- No other concurrent EGFR inhibitors or cyclo-oxygenase-2 (COX-2) inhibitors
- Meets 1 of the following criteria: 1) Advanced NSCLC with at least stable disease after >= 4 courses of platinum-containing chemotherapy 2) Relapsed or refractory disease after treatment with >= 1 prior platinum-containing chemotherapy program, including adjuvant or neoadjuvant therapy for NSCLC
- No untreated brain metastases
- ECOG 0-1
- Former smoker, as indicated by the following: 1) At least a 30 pack-year smoking history 2) Smoking duration at least 10 years 3) At least 12 months of self-reported smoking cessation 4) Negative urine cotinine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (erlotinib hydrochloride, celecoxib)
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given orally
Other Names:
Given orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical tolerable dose of celecoxib as measured by NCI CTCAE v3.0
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Kelley, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Erlotinib Hydrochloride
- Celecoxib
Other Study ID Numbers
- NCI-2009-00886
- 4939-04-6R2
- DUMC-4939-03-6R0
- VAMC-DURHAM-00813
- DUMC-GCRC-911
- CDR0000377689
- DUMC-4939-04-6R2
- U01CA096123 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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