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Combination Chemotherapy and Celecoxib in Treating Patients With Advanced 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 Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy and Celecoxib in Treating Patients With Advanced 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 Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer. Combination Chemotherapy and Celecoxib in Treating Patients With Advanced 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 Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Combination Chemotherapy and Celecoxib in Treating Patients With Advanced 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 > Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer  Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Combination Chemotherapy and Celecoxib 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
Status: Recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Combining celecoxib with combination chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining irinotecan and docetaxel with celecoxib in treating patients who have advanced non-small cell lung cancer.
Details: OBJECTIVES: - Determine the recommended phase II dose of docetaxel and irinotecan in combination with celecoxib in patients with advanced non-small cell lung cancer. - Determine the toxic effects of this regimen in these patients. - Determine the response rate of patients treated with this regimen. - Determine the progression-free and overall survival of patients treated with this regimen. - Determine the pharmacokinetics of this regimen in these patients. - Correlate angiogenesis markers (intratumoral microvessel density and vascular endothelial growth factor [VEGF] expression and serum VEGF) and cyclooxygenase-2 expression with response and survival in patients treated with this regimen. - Correlate UGT1A1 genotype and CYP3A4 activity with the toxic effects of this regimen in these patients. OUTLINE: This is a dose-escalation study of docetaxel and irinotecan. - Patients receive docetaxel IV over 60 minutes and irinotecan IV over 30 minutes on days 1 and 8. Patients also receive oral celecoxib twice daily beginning on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of docetaxel and irinotecan until the recommended phase II dose is determined. The recommended phase II dose is defined as the highest dose at which 0 of 3 or 1 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive treatment as in phase I at the recommended phase II dose. Patients are followed every 3 months until disease progression. PROJECTED ACCRUAL: A total of 3-70 patients (3-36 for phase I and 16-34 for phase II) will be accrued for this study.
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) meeting 1 of the following criteria: - Stage IV - Stage IIIB with a malignant pleural effusion - Locally recurrent and/or persistent disease after locoregional therapy with or without systemic chemotherapy - Unidimensionally measurable disease - If the only site of measurable disease is in a previously irradiated area must have documented progression of disease in that area - No CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - AST and ALT less than 2.5 times upper limit of normal (ULN) (if alkaline phosphatase is normal) - Alkaline phosphatase less than 4 times ULN (if AST and ALT are normal) Renal - Creatinine less than 2.0 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study treatment - No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix - No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days - No prior hypersensitivity to cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, sulfonamides, or drugs formulated with polysorbate 80 - No pre-existing grade 2 or greater peripheral neuropathy - No concurrent medical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - At least 1 week since prior biologic therapy - Phase I patients: - Any number of prior biologic therapies allowed (e.g., chimeric antibodies or kinase inhibitors) - Phase II patients: - No prior biologic therapy for recurrent/metastatic disease - No concurrent filgrastim (G-CSF) Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy - No prior irinotecan or docetaxel - Phase I patients: - Up to 2 prior chemotherapy regimens for recurrent/metastatic disease allowed (chemonaïve patients are also eligible) - Phase II patients: - At least 1 year since prior adjuvant or neoadjuvant chemotherapy for stage I-IIIA disease - No prior chemotherapy for recurrent/metastatic disease Endocrine therapy - Less than 2 weeks of cumulative oral/IV corticosteroid use within the past 3 months Radiotherapy - See Disease Characteristics - Recovered from prior radiotherapy - At least 3 weeks since prior extensive-field radiotherapy for recurrent/metastatic disease Surgery - Recovered from prior surgery Other - More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis - No prior NSAIDs at a frequency of more than 3 times per week for a cumulative period of more than 2 weeks within the past 30 days - No concurrent antiepileptics, cyclosporine, aspirin, or fluconazole - No concurrent NSAIDs - No other concurrent COX-2 inhibitors
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AthanassiosArgiris, Study Chair, Robert H. Lurie Cancer Center
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Athanassios Argiris 312-695-4441
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Thomas Hensing 847-570-2110
Silver Cross Hospital *Recruiting*
Joliet, Illinois, 60432
United States
Recruiting Lawrence Schilder 815-740-1400
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611-3013
United States
Recruiting Athanassios Argiris 312-695-4441
Additional Information:
Study ID Numbers: CDR0000285672; NU-01L2,PHARMACIA-NU-01L2
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073866
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
2. Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
3. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
4. Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
5. Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
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