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Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer Clinical research trials and Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer. Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer  Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer
Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer
For Condition: Non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Cell Pathways ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if docetaxel is more effective with or without exisulind in treating non-small cell lung cancer. PURPOSE: Randomized phase III trial to study the effectiveness of docetaxel with or without exisulind in treating patients who have advanced non-small cell lung cancer that has not responded to previous treatment. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to performance status (0 vs 1 vs 2) and extent of disease (locally advanced vs metastatic). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral exisulind twice daily beginning on days -3 and continuing through day 21. Patients receive docetaxel IV over 1 hour on day 0. Arm II: Patients receive oral placebo twice daily beginning on day -3 and continuing through day 21. Patients receive docetaxel as in arm I. For subsequent courses, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 30 days.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1. Histologically or cytologically documented non-small cell lung cancer. At the time of entry, patients must have locally advanced (Stage IIIb) or metastatic (Stage IV) disease. 2. Progressive disease while receiving or after completing platinum-based chemotherapy. 3. Patients must have measurable or nonmeasurable disease per RECIST criteria. Patients whose disease cannot be adequately assessed for progression (?truly nonmeasurable? disease) are excluded. See exclusion criterion #4. 4. No treatment with any chemotherapy or radiotherapy to more than 25% of the bone marrow within 3 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy. 5. Expected remaining life span > or = three months. 6. ECOG performance status 0 ? 2. 7. 18 years or of legal age. 8. Male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal. 9. Negative serum pregnancy test, if female of child bearing potential. 10. Willingness to remain off chronic NSAIDs (with the exception of ibuprofen or naproxen), including COX 2 inhibitors and salicylates (e.g., aspirin, mesalamine, azodisalicylate, salsalate, sulfasalazine) for the duration of the study. Patients on low dose aspirin for cardiovascular prevention may be included in the study. Acetaminophen is not an NSAID, and is not prohibited. 11. No sulindac (Clinoril) on regular basis for any indication for one week prior to enrollment and willing to remain off sulindac for the duration of the study. 12. Willingness and ability to sign an informed consent document. Exclusion Criteria: 1. Known hypersensitivity to sulindac (Clinoril); taxanes or other drugs formulated with polysorbate 80. 2. Uncontrolled or symptomatic brain metastases. 3. Use of an investigational medication or device within one month of initiating study therapy. 4. Patients with one or more of the following as the only manifestations of disease are ineligible: - Osteoblastic bone lesions - leptomeningeal disease - ascites - pleural/pericardial effusions - carcinomatous lymphangitis - CNS metastases - lesions in a previously irradiated area that have not shown definite progression - or disease only inferred from laboratory tests or markers 5. Patients with elevation of AST or ALT > 1.5 times the upper limit of normal are excluded. 6. Absolute granulocyte count < or = 1500/mm3; Platelet count < or = 100,000/ mm3; total serum bilirubin above the upper limit of normal patients with elevated indirect bilirubin due to Gilbert?s syndrome will be eligible); serum creatinine above the upper limit of normal (patients with estimated creatinine clearance (Cockroft-Gault) greater than 60 ml/min will be eligible). 7. Prior treatment with docetaxel (prior treatment with paclitaxel is allowed). 8. Any condition or any medication that may interfere with the conduct of the study. 9. Peripheral neuropathy > or = grade 2.
Total Enrollment: 600
Location and Contact Information:
Overall Study Official:
RobertBellet, Study Chair, Cell Pathways
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
United States
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
Northwest Medical Specialists, P.C.
Niles, Illinois, 60714
United States
Oncology and Hematology Associates
Indianapolis, Indiana, 46227
United States
Texas Oncology
Ft. Worth, Texas, 76104
United States
Puget Sound Cancer Center
Edmonds, Washington, 98026
United States
Allison Cancer Center
Midland, Texas, 79701
United States
Texas Oncology, P.A.
Bedford, Texas, 76022
United States
Texas Oncology, P.A.
Abilene, Texas, 79601
United States
Texas Oncology
Ft. Worth, Texas, 76104
United States
Asheville Hematology and Oncology Associates, P.A.
Asheville, North Carolina, 28801
United States
Texas Oncology, P.A.
Irving, Texas, 75061
United States
Albany Regional Cancer Center
Albany, New York, 12208
United States
Rocky Mountain Cancer Centers
Littleton, Colorado, 80120
United States
Waco Cancer Care
Waco, Texas, 76712
United States
Central Maryland Oncology, P.A.
Towson, Maryland, 21204
United States
Texas Cancer Center
Mesquite, Texas, 75150
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, 92708
United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218
United States
Texas Oncology, P.A.
Houston, Texas, 77029-1293
United States
Minnesota Oncology-Hematology, P.A.
Minneapolis, Minnesota, 55407
United States
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, 59101
United States
Raleigh Hematology Oncology Clinic - Cary
Cary, North Carolina, 27511
United States
San Antonio Tumor and Blood Clinic
San Antonio, Texas, 78217
United States
Ocala Oncology Center
Ocala, Florida, 34474
United States
North Florida Hematology & Oncology Associates
Jacksonville, Florida, 32204
United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, 33428
United States
Washington Cancer Center, P.C.
Seattle, Washington, 98133
United States
Northwest Cancer Specialists
Vancouver, Washington, 98664
United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80933
United States
Arizona Hematology & Oncology Associates
Phoenix, Arizona, 85012
United States
Lauderhill Lakes
Plantation, Florida, 33324
United States
Texas Oncology, P.A.
Houston, Texas, 77024
United States
Midwest Cancer Research Group, Inc.
Northfield, Illinois, 60093
United States
Cancer Care Associates
Tulsa, Oklahoma, 74136
United States
South Austin Cancer Center
Austin, Texas, 78745
United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505-7670
United States
Birmingham Hematology Oncology Associates
Birmingham, Alabama, 35205
United States
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, 11733
United States
Steven Abrams and Andrew Schneider Associates
Lauderhill, Florida, 33319
United States
Arch Medical Center, LLC
St. Louis, Missouri, 63141
United States
Texas Oncology, P.A.
Houston, Texas, 77030
United States
Triad Hematology-Oncology (US Oncology)
Winston Salem, North Carolina, 27103
United States
Minnesota Oncology-Hematology, P.A.
St. Paul, Minnesota, 55102
United States
Regional Hematology/Oncology
Durham, North Carolina, 27704
United States
Iowa Oncology Associates
Cedar Rapids, Iowa, 52403
United States
Rocky Mountain Cancer Centers - Northern Colorado
Fort Collins, Colorado, 80524-4038
United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, 84124
United States
Midwest Oncology Consortium
Kansas City, Missouri, 64111
United States
Arkansas Oncology Associates, P.A.
Little Rock, Arkansas, 72207
United States
Northern Arizona Hematology and Oncology Associates
Flagstaff, Arizona, 85712
United States
Cancer Research of Long Island, Inc.
Great Neck, New York, 11022
United States
Raleigh Hematology Oncology Associates, P.C.
Raleigh, North Carolina, 27607
United States
Central Maryland Oncology, P.A.
Columbia, Maryland, 21044
United States
Ranier Oncology Professional Services
Puyallup, Washington, 98372
United States
Cancer Care Northwest
Spokane, Washington, 99202
United States
Scripps Clinic Cancer Center
La Jolla, California, 92037
United States
Rocky Mountain Cancer Centers
Thornton, Colorado, 80221
United States
Williamette Valley Cancer Center (US Oncology)
Eugene, Oregon, 97401
United States
Texas Cancer Center
Dallas, Texas, 75237
United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702
United States
HemOnCare, PC
Brooklyn, New York, 11235
United States
West Texas Cancer Center
Odessa, Texas, 79761
United States
Rocky Mountain Cancer Center
Boulder, Colorado, 80304
United States
Texas Oncology, P.A.
Garland, Texas, 75042
United States
Capitol District Hematology/Oncology Associates
Albany, New York, 12208
United States
California Cancer Care, Inc.
Greenbrae, California, 94904
United States
Missouri Cancer Associates
Columbia, Missouri, 65201
United States
Texas Oncology, P.A.
Dallas, Texas, 75231
United States
Florida Oncology Associates
Orange Park, Florida, 32073
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Cancer Care Associates - West
Oklahoma City, Oklahoma, 73112
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Lake Vista Cancer Center
Lewisville, Texas, 75067
United States
Hematology & Oncology Associates of Jacksonville
Jacksonville, Florida, 32207
United States
Hematology/Oncology Associates of South Texas
San Antonio, Texas, 78229
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Marian Cheney Olrogg Regional Oncology Center
Tacoma, Washington, 98405
United States
Sharp Health Care
San Diego, California, 92121
United States
Rocky Mountain Cancer Center
Englewood, Colorado, 80110
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Hematology/Oncology Group
Santa Rosa, California, 94904
United States
Raleigh Hematology Oncology Clinic - Raleigh
Raleigh, North Carolina, 27609
United States
Fox Chase - Temple Cancer Center
Philadelphia, Pennsylvania, 19140
United States
Texas Oncology, P.A.
Arlington, Texas, 76012
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Texoma Cancer Center - Denison
Denison, Texas, 75020
United States
Texas Oncology, P.A.
Houston, Texas, 77074
United States
Tyler Cancer Center
Tyler, Texas, 75702
United States
Florida Community Cancer Center
New Port Richey, Florida, 34652
United States
Cancer Centers of Florida (US Oncology)
Orlando, Florida, 32806
United States
Medical Oncology Associates of Wymoning Valley
Kingston, Pennsylvania, 18704
United States
Oncology/Hematology Associates - Beaver
Beaver, Pennsylvania, 15009
United States
Virginia Oncology Associates (US Oncology)
Newport News, Virginia, 23606
United States
Texas Oncology, P.A. (TOPA) at Baylor-Sammons
Dallas, Texas, 75246
United States
Northwestern Carolina Oncology and Hematology
Hickory, North Carolina, 28601
United States
Texas Cancer Center
Dallas, Texas, 75230
United States
Dayton Oncology/Hematology, P.A.
Dayton, Ohio, 45439
United States
Additional Information:
Study ID Numbers: Study 028;
Study Start Date: March 2001
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036322
Other Non-Small Cell Lung Cancer Studies:
1. Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
2. Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
3. Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer
4. Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
5. Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer
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Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer
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