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Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer Clinical research trials and Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer. Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer  Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: Recruiting
Sponsor(s): Barbara Ann Karmanos Cancer Institute ,
Synopsis: RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of celecoxib and docetaxel in treating patients who have non-small cell lung cancer.
Details: OBJECTIVES: - Determine the efficacy and feasibility of celecoxib combined with docetaxel as first-line therapy in elderly or poor performance status patients with advanced non-small cell lung cancer. - Determine the response rate of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral celecoxib twice daily (beginning on day -7 of the first course) and docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses after CR. Patients who achieve stable disease (SD) or a partial response (PR) receive a minimum of 2 additional courses after SD or PR. At the discretion of the treating physician, patients then receive maintenance therapy comprising celecoxib only. Patients who discontinue therapy for disease progression or unacceptable toxicity are followed for at least 6 months. PROJECTED ACCRUAL: A total of 21-39 patients will be accrued for this study within 13-28 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of non-small cell lung cancer (NSCLC) - Stage IIIB with pleural effusion or stage IV disease - Age 70 years and over with SWOG performance status 0-2 OR age 18 to 69 with SWOG performance status 2 - Measurable or evaluable disease - No symptomatic or untreated brain or leptomeningeal metastases - Previously treated patients must be neurologically stable for 4 weeks after completion of appropriate therapy PATIENT CHARACTERISTICS: Age: - See Disease Characteristics - 18 and over Performance status: - See Disease Characteristics - SWOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 8 g/dL Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - AST/ALT no greater than ULN (or no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN) - Alkaline phosphatase no greater than ULN (or no greater than 5 times ULN if AST/ALT no greater than ULN) - No history of chronic hepatitis Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No uncontrolled congestive heart failure - No uncontrolled angina - No myocardial infarction and/or stroke within the past 6 months - No active thromboembolic event within the past 4 weeks Gastrointestinal: - No gastrointestinal bleeding within the past 6 months - No history of peptic ulcer disease Other: - No prior hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 - No prior allergy to any non-steroidal anti-inflammatory drug - No other prior or concurrent malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix - No grade 2 or greater peripheral neuropathy - No other serious concurrent medical illness - No history of dementia, active psychiatric disorder, or other condition that would interfere with ability to take oral medication or preclude compliance with study - HIV negative - Must weigh at least 50 kg (110 pounds) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy for NSCLC Chemotherapy: - No prior chemotherapy for NSCLC Endocrine therapy: - At least 3 days since prior steroids Radiotherapy: - At least 4 weeks since prior radiotherapy - No prior radiotherapy to target lesion Surgery: - At least 4 weeks since prior major surgery Other: - Prior intermittent use of non-steroidal anti-inflammatory drugs (NSAIDs), including rofecoxib or celecoxib, allowed - At least 1 week since prior fluconazole - No recent prior NSAIDs, including rofecoxib or celecoxib, for a duration of more than 30 consecutive days - No concurrent fluconazole or lithium - No concurrent NSAIDs except aspirin administered at a dose of no more than 325 mg/day for cardiovascular conditions - No other concurrent cyclo-oxygenase-2 inhibitors - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ShirishGadgeel, Study Chair, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Shirish Gadgeel 313-745-8389
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0922
United States
Recruiting Gregory Kalemkerian 734-936-5281
Additional Information:
Study ID Numbers: CDR0000069163; NCI-V01-1687,WSU-06-15-01-M01-FB,WSU-C-2305,AVENTIS-WSU-C-2305
Study Start Date:
Record last reviewed: February 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030407
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Chemotherapy, Tirapazamine, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
2. Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
3. Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
4. Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
5. Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
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