Status:
COMPLETED
Celecoxib and Erlotinib in Treating Former Smokers With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating former smokers with stage IIIB, stage IV, recurrent, or progressive non-small ...
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00088959
Start Date
December 1 2003
End Date
November 1 2010
Last Update
October 10 2014
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710