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Clinical Trial Name - Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell
| Original Study ID : CDR0000304495 |
| Secondary ID : Array |
| NCT ID : NCT00062101 |
| Brief Title : Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer |
| Official Title : A Phase II Study Of OSI 774 (IND Number 63383) In Combination With Celecoxib (Celebrex, Pharmacia) As Second-Line Therapy In Advanced Non-Small Cell Lung Cancer |
| Brief Summary : RATIONALE: Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of a tumor by stopping blood flow to the tumor. Combining erlotinib with celecoxib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving erlotinib together with celecoxib works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer. |
| Source : National Cancer Institute (NCI) |
| Detailed Description : OBJECTIVES: - Determine the response rate of patients with stage IIIB or IV recurrent non-small cell lung cancer treated with erlotinib and celecoxib as second-line therapy. - Determine the time to progression in patients treated with this regimen. - Determine the survival duration of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. - Correlate the expression of epidermal growth factor receptor and cyclooxygenase-2 in tumor specimens with response, time to progression, and survival in patients treated with this regimen. OUTLINE: Patients are assigned to 1 of 2 treatment groups. - Group 1: Patients receive oral erlotinib once daily and oral celecoxib twice daily. - Group 2: Patients receive erlotinib as in group 1. Treatment in both groups continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 10 months. |
| Overall Status : Completed |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Treatment, Open Label |
| Verification Date : July 2008 |
| First Received Date : June 5, 2003 |
| Trial Eligibility |
| Criteria : DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer - Stage IIIB (malignant pleural effusion only) or IV - Recurrent disease that has progressed after 1 or 2 prior chemotherapy regimens (platinum- or nonplatinum-based) - At least 1 unidimensionally measurable lesion* - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: *The sole measurable lesion must not be in a previously irradiated field - Must have tissue specimen available for assays - No brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - AST/ALT no greater than 2.5 times upper normal limit (ULN) Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Ophthalmic - No prior abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) - No congenital abnormality (e.g., Fuch's dystrophy) - No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) Gastrointestinal - Able to ingest oral medication - No requirement for IV alimentation - No history of peptic ulcer disease - No active gastrointestinal ulcers Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other concurrent uncontrolled illness - No ongoing or active infection - No significant traumatic injury within the past 21 days - No psychiatric illness or social situation that would preclude study compliance - No prior allergic reactions to sulfonamides, aspirin, and other nonsteroidal anti-inflammatory drugs PRIOR CONCURRENT THERAPY: Biologic therapy - No prior monoclonal antibodies to epidermal growth factor receptor (EGFR) Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No concurrent chemotherapy Endocrine therapy - No concurrent glucocorticoids Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy and recovered Surgery - More than 21 days since prior major surgery - No prior surgery affecting absorption Other - No prior EGFR-specific tyrosine kinases - No concurrent anticonvulsants - No other concurrent investigational agents - No concurrent antiretroviral therapy for HIV-positive patients - No concurrent antacids - No concurrent administration of any of the following drugs: - Amiodarone - Chloramphenicol - Cimetidine - Fluvoxamine - Omeprazole - Zafirlukast - Clopidogrel - Cotrimoxazole - Disulfiram - Fluconazole - Fluoxetine - Fluvastatin - Fluvoxamine - Isoniazid - Itraconazole - Ketoconazole - Leflunomide - Metronidazole - Modafinil - Paroxetine - Phenylbutazone - Sertraline - Ticlopidine - Valproic acid |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Interventions |
| Type : Drug |
| Name : celecoxib |
| Type : Drug |
| Name : erlotinib hydrochloride |
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