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Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer Clinical research trials and Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer. Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer  Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Rush Cancer Institute at Rush University Medical Center , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of combining erlotinib with celecoxib in treating patients who have recurrent stage IIIB or stage IV non-small cell lung cancer.
Details: 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: This is a randomized study. Patients receive oral erlotinib once daily and oral celecoxib twice daily. Treatment 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 and only 1 prior chemotherapy regimen (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 active 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PhilipBonomi, Study Chair, Rush Cancer Institute at Rush University Medical Center
Additional Information:
Study ID Numbers: CDR0000304495; NCI-5416,RUSH-LUNG-2001-1
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062101
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors
2. Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
3. ZD1839 Plus Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
4. Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
5. Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer
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Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
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