Celecoxib and Erlotinib in Treating Former Smokers With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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 cell lung cancer. Celecoxib and erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Celecoxib; Erlotinib Hydrochloride

Criteria

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