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Celecoxib and Docetaxel in Treating Patients With Advanced 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 Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer Clinical research trials and Celecoxib and Docetaxel in Treating Patients With Advanced 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 Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer. Celecoxib and Docetaxel in Treating Patients With Advanced 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 Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Celecoxib and Docetaxel in Treating Patients With Advanced 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 > "C" Clinical Trials Conditions > Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer  Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
Celecoxib and Docetaxel in Treating Patients With Advanced 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,stage 3A non-small cell lung cancer
Status: Suspended
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 with celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and docetaxel in treating patients who have advanced non-small cell lung cancer that has been previously treated with platinum -based chemotherapy.
Details: OBJECTIVES: I. Determine the efficacy and feasibility of celecoxib combined with docetaxel in patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy. II. Determine the response rate of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. PROTOCOL 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 day 1. Treatment repeats every 21 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:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of stage IIIA, IIIB, or IV non-small cell lung cancer; Disease progression during or after 1 or more platinum-based chemotherapy regimens - 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 --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy; Prior paclitaxel allowed; No prior docetaxel - 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 other 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 --Patient Characteristics-- - Age: 18 and over - Performance status: SWOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; 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 of any duration - Renal: Creatinine no greater than 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 active infection; 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ShirishGadgeel, Study Chair, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Additional Information:
Study ID Numbers: CDR0000069164; WSU-06-08-01-M01-FB,WSU-C-2304,AVENTIS-WSU-C-2304,NCI-V01-1688
Study Start Date: October 2001
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030420
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
2. Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
3. Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
4. Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
5. Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other Michigan Clinical Trials
Other Ann Arbor Clinical Trials
Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
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