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Clinical Trial Name - Celecoxib and Erlotinib in Treating Former Smokers With Stage IIIB or Stage IV Non-Small Cell Lung
| Original Study ID : CDR0000377689 |
| Secondary ID : Array |
| NCT ID : NCT00088959 |
| Brief Title : Celecoxib and Erlotinib in Treating Former Smokers With Stage IIIB or Stage IV Non-Small Cell Lung Cancer |
| Official Title : Phase I Study of Erlotinib and Celecoxib in Former Smokers With Advanced Non-Small Cell Lung Cancer |
| Brief Summary : RATIONALE: Celecoxib and erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: 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 |
| Source : National Cancer Institute (NCI) |
| Detailed Description : OBJECTIVES: Primary - Determine the clinical toxicity and tolerability of celecoxib and erlotinib hydrochloride in former smokers with stage IIIB or IV or recurrent or progressive non-small cell lung cancer. Secondary - Determine the tumor response rate in patients treated with this regimen. - Determine the dose of celecoxib that results in maximal induction of apoptosis, maximal inhibition of prostaglandin E_2 (PGE_2) in bronchoalveolar fluid, and maximal inhibition of bronchial cell proliferation in patients treated with this regimen. 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. PROJECTED ACCRUAL: A total of 6-45 patients will be accrued for this study. |
| Overall Status : Active, not recruiting |
| Start Date : September 2004 |
| Official Title : Phase 1 |
| Phase : Interventional |
| Study Design : Treatment, Open Label |
| Enrollment : 45 |
| Verification Date : October 2007 |
| First Received Date : August 4, 2004 |
| Trial Eligibility |
| Criteria : DISEASE CHARACTERISTICS: - 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 - Meets 1 of the following criteria: - Advanced NSCLC with at least stable disease after ≥ 4 courses of platinum-containing chemotherapy - Relapsed or refractory disease after treatment with ≥ 1 prior platinum-containing chemotherapy program, including adjuvant or neoadjuvant therapy for NSCLC - 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 - Former smoker, as indicated by the following: - At least a 30 pack-year smoking history - Smoking duration at least 10 years - At least 12 months of self-reported smoking cessation - Negative urine cotinine - No untreated brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 10 g/dL - Hemostasis normal Hepatic - Bilirubin ≤ 2.0 mg/dL - PT/PTT within 0.5 seconds of normal Renal - Creatinine ≤ 2.0 mg/dL Cardiovascular - 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 Pulmonary - FEV_1 ≥ 1.0 liter OR 40% of predicted within the past 3 months - Oxygen saturation ≥ 90% on room air Other - 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 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin) Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy Surgery - See Disease Characteristics - Prior complete resection allowed provided there is histologic and cytologic documentation of disease recurrence Other - 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 |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Duke Comprehensive Cancer Center |
| City : Durham |
| State : North Carolina |
| Zip Code : 27710 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Durham |
| City : Durham |
| State : North Carolina |
| Zip Code : 27705 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Measure : Clinical toxicity and tolerability as measured by NCI CTCAE v3.0 and protocol-specific definition of dose-limiting toxicity at 4 weeks after initiation of study treatment |
| Safety issue : Yes |
| Secondary OutComes |
| Measure : Tumor response rate as measured by RECIST at 4 weeks after initiation of study treatment and periodically thereafter |
| Safety issue : No |
| Measure : Effect of study drugs on biomarkers at 4 weeks after initiation of study treatment |
| Safety issue : No |
| Interventions |
| Type : Drug |
| Name : celecoxib |
| Type : Drug |
| Name : erlotinib hydrochloride |
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