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Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton 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. Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer Clinical research trials and Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer. Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer clinical trial. Participants frequently get the best healthcare available for their Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.

Home > "C" Clinical Trials Conditions > Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer

Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer



Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer

For Condition: large cell lung cancer,stage 4 non-small cell lung cancer,squamous cell lung cancer,stage 3B non-small cell lung cancer,adenocarcinoma of the lung
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib and zileuton may stop the growth of tumor cells by stopping blood flow to the tumor and may block the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib and/or zileuton may kill more tumor cells. PURPOSE: Randomizedphase II trial to study the effectiveness of combining celecoxib and/or zileuton with carboplatin and gemcitabine in treating patients who have advanced non-small cell lung cancer.
Details: OBJECTIVES: Primary - Compare the efficacy of carboplatin and gemcitabine with celecoxib and/or zileuton, in terms of 7-month progression-free survival, in patients with advanced non-small cell lung cancer. Secondary - Compare the response rate, distribution of survival, and failure-free survival time of patients treated with these regimens. - Correlate CYFRA and serum vascular endothelial growth factor levels with response and survival of patients treated with these regimens. - Correlate cyclo-oxygenase-2 and 5-lipoxygenase expression with survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and oral zileuton 4 times daily on days 1-21. - Arm II: Patients receive gemcitabine and carboplatin as in arm I and oral celecoxib twice daily on days 1-21. - Arm III: Patients receive gemcitabine and carboplatin as in arm I, oral celecoxib as in arm II, and oral zileuton as in arm I. In all arms, treatment repeats every 21 days for 6 courses. Patients with responding or stable disease continue courses of zileuton and/or celecoxib in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 1 year, every 2 months for 2 years, and then every 4 months for 3 years or until disease progression. PROJECTED ACCRUAL: A total of 117 patients (39 per treatment arm) will be accrued for this study within 11-12 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 (NSCLC) of 1 of the following cellular types: - Adenocarcinoma - Large cell - Squamous cell - Mixed - Meets 1 of the following staging criteria: - Stage IIIB disease with malignant pleural effusion, supraclavicular node involvement, or contralateral hilar nodes - Stage IIIB patients eligible for Cancer and Leukemia Group B protocols of combined chemotherapy and chest irradiation are not allowed - Stage IV disease - Measurable or nonmeasurable disease - Unidimensionally measurable lesions at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - The following are considered nonmeasurable disease: - Bone lesions - Ascites - Pleural/pericardial effusion - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Small lesions - No leptomeningeal disease - Symptomatic CNS metastases must be treated (e.g., surgery, radiotherapy, or gamma knife), neurologically stable, and off steroids PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - AST no greater than 2.0 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - None of the following within the past 6 months: - Myocardial infarction - Unstable angina - Symptomatic congestive heart failure - Serious uncontrolled cardiac arrhythmia - Cerebrovascular accident - Transient ischemic attack - Symptomatic carotid artery or peripheral vascular disease - Deep vein thrombosis - Significant thromboembolic event Pulmonary - No pulmonary embolism within the past 6 months Gastrointestinal - No history of gastrointestinal (GI) bleeding - No history of peptic ulcer disease - No active GI bleeding Other - Not pregnant or nursing - No known hypersensitivity to aspirin, NSAIDs, or sulfonamides - No currently active second malignancy other than nonmelanoma skin cancer - Patients are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy for NSCLC Chemotherapy - No prior chemotherapy for NSCLC - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - No concurrent chronic oral steroids - Concurrent episodic steroids for antiemetic purposes allowed - No concurrent hormonal therapy - Concurrent inhaled steroids allowed when medically indicated - Concurrent megestrol for appetite stimulation is allowed Radiotherapy - See Disease Characteristics - At least 2 weeks since prior radiotherapy and recovered Surgery - See Disease Characteristics - At least 2 weeks since prior surgery and recovered Other - No prior systemic treatments for NSCLC - No other concurrent investigational therapy - No concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), including any of the following: - Rofecoxib - Choline magnesium trisalicylate - Ibuprofen - Naproxen - Etodolac - Oxaprozin - Diflunisal - Nabumetone - Tolmetin - Valdecoxib - No concurrent chronic aspirin - Concurrent aspirin no greater than 325 mg/day is allowed - No concurrent fluconazole - No concurrent leukotriene antagonists (e.g., zafirlukast, montelukast, or pranlukast)
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MartinEdelman,  Study Chair,  University of Maryland Greenebaum Cancer Center

Baptist Hospital East - Louisville *Recruiting*
Louisville,  Kentucky,  40207
United States
Recruiting Daniel  Scullin 502-897-1166

New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett,  New Hampshire,  03106
United States
Recruiting Douglas  Weckstein 603-622-6484

Missouri Baptist Cancer Center *Recruiting*
St. Louis,  Missouri,  63131
United States
Recruiting Alan  Lyss 314-996-5514

University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester,  Massachusetts,  01655
United States
Recruiting Pankaj  Bhargava 508-856-6884

Veterans Affairs Medical Center - Buffalo *Recruiting*
Buffalo,  New York,  14215
United States
Recruiting Lynn  Steinbrenner 716-862-3191

Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem,  North Carolina,  27157-1082
United States
Recruiting David  Hurd 336-716-2088

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-271-4022

Walter Reed Army Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20307-5000
United States
Recruiting Joseph  Drabick 202-782-6751

West Suburban Center for Cancer Care *Recruiting*
River Forest,  Illinois,  60305
United States
Recruiting John  Showel 708-763-2700

Duke Comprehensive Cancer Center *Recruiting*
Durham,  North Carolina,  27710
United States
Recruiting Jeffrey  Crawford 919-684-5195

Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood,  Florida,  33021
United States
Recruiting Atif  Hussein 954-986-6363

MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Lawrence  Feldman 312-335-3614

CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend,  Indiana,  46601
United States
Recruiting Rafat  Ansari 574-284-7977

Veterans Affairs Medical Center - White River Junction *Recruiting*
White River Junction,  Vermont,  05009
United States
Recruiting Joseph  O'Donnell 802-295-9363 ext. 5480

Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas,  Nevada,  89106
United States
Recruiting Chitha  Hulugalle 702-696-3000

Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk,  Virginia,  23502
United States
Recruiting Paul  Conkling 757-466-8683

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Clifford  Hudis 212-639-6483

Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego,  California,  92161
United States
Recruiting Saeeda  Kirmani 619-552-8585 ext. 3356

CCOP - Christiana Care Health Services *Recruiting*
Newark,  Delaware,  19713
United States
Recruiting Stephen  Grubbs 302-623-4100

Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis,  Minnesota,  55417
United States
Recruiting Vicki  Morrison 612-725-2000 ext. 4135

Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City,  Iowa,  52242-1009
United States
Recruiting Gerald  Clamon 319-356-1932

Lifespan: The Miriam Hospital *Recruiting*
Providence,  Rhode Island,  02906
United States
Recruiting William  Sikov 401-793-7151

Mount Sinai Medical Center, NY *Recruiting*
New York City,  New York,  10029
United States
Recruiting Lewis  Silverman 212-241-5520

Barnes-Jewish Hospital *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Nancy  Bartlett 314-747-3000

NorthEast Oncology Associates *Recruiting*
Concord,  North Carolina,  28025
United States
Recruiting James  Wall 704-783-1370

CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas,  Nevada,  89106
United States
Recruiting John  Ellerton 702-384-0013

Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Thomas  Lad 312-996-2046

University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse,  New York,  13210
United States
Recruiting Stephen  Graziano 315-464-8200

Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne,  Indiana,  46885-5099
United States
Recruiting Sreenivasa  Nattam 219-484-8830

CCOP - Illinois Oncology Research Association *Recruiting*
Peoria,  Illinois,  61602
United States
Recruiting John  Kugler 309-636-3605

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse,  New York,  13217
United States
Recruiting Jeffrey  Kirshner 315-472-7504

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill,  North Carolina,  27599-7295
United States
Recruiting Thomas  Shea 919-966-7746

Veterans Affairs Medical Center - Syracuse *Recruiting*
Syracuse,  New York,  13210
United States
Recruiting Stephen  Graziano 315-476-7461

MBCCOP - Massey Cancer Center *Recruiting*
Richmond,  Virginia,  23298-0037
United States
Recruiting John  Roberts 804-828-0450

Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75216
United States
Recruiting Barry  Levinson 214-648-4193

New Hanover Regional Medical Center *Recruiting*
Wilmington,  North Carolina,  28402-9025
United States
Recruiting Cyrus  Kotwall 910-763-4630

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting George  Canellos 617-632-3470

Vermont Cancer Center at University of Vermont *Recruiting*
Burlington,  Vermont,  05401-3498
United States
Recruiting Hyman  Muss 802-847-3827

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting Karen  Wendling 773-834-7424

CCOP - Evanston *Recruiting*
Evanston,  Illinois,  60201
United States
Recruiting Gershon  Locker 847-570-2518

Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C.,  District of Columbia,  20422
United States
Recruiting Steven  Krasnow 202-745-8178

Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore,  Maryland,  21201
United States
Recruiting Martin  Edelman 410-328-2703

CCOP - Mount Sinai Medical Center *Recruiting*
Miami,  Florida,  33140
United States
Recruiting Rogerio  Lilenbaum 305-674-2625

CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem,  North Carolina,  27104-4241
United States
Recruiting James  Atkins 336-777-3036

Northeast Alabama Regional Medical Center *Recruiting*
Anniston,  Alabama,  36207
United States
Recruiting Thomas  Twele 256-236-2549

North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Daniel  Budman 516-562-8958

Broward General Medical Center *Recruiting*
Ft. Lauderdale,  Florida,  33316
United States
Recruiting Luis  Barreras 954-771-0692

Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica,  New York,  11432
United States
Recruiting Hans  Grunwald 718-883-4118

Western Pennsylvania Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15224
United States
Recruiting Richard  Shadduck 412-578-4355

UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha,  Nebraska,  68198-7680
United States
Recruiting Margaret  Kessinger 402-559-7511

Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon,  New Hampshire,  03756-0002
United States
Recruiting Marc  Ernstoff 603-650-5534

Saint Anthony Medical Center *Recruiting*
Rockford,  Illinois,  61108
United States
Recruiting Richard  Nora 815-227-2273

Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus,  Ohio,  43210-1240
United States
Recruiting Clara  Bloomfield 614-293-7518

University of Minnesota Cancer Center *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Bruce  Peterson 612-624-5631

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

Martha Jefferson Hospital *Recruiting*
Charlottesville,  Virginia,  22902
United States
Recruiting Stefan  Gorsch 434-982-8410

Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia,  Missouri,  65203
United States
Recruiting Michael  Perry 573-882-4979

CCOP - North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Vincent  Vinciguerra 516-562-8915

St. Mary's Medical Center *Recruiting*
Huntington,  West Virginia,  25701
United States
Recruiting Gerrit  Kimmey 304-528-4645

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75390
United States
Recruiting Debasish  Tripathy 214-648-5113

Cape Fear Valley Health System *Recruiting*
Fayetteville,  North Carolina,  28302-2000
United States
Recruiting Kamal  Bakri 910-609-6910

FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst,  North Carolina,  28374
United States
Recruiting Ellen  Willard 910-295-9205

Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco,  California,  94121
United States
Recruiting Patricia  Cornett 415-221-4810 ext. 3423

Louis A. Weiss Memorial Hospital *Recruiting*
Chicago,  Illinois,  60640
United States
Recruiting Keith  Shulman 773-564-5022

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles,  California,  90048
United States
Recruiting Alan  Lefor 310-423-5874

Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville,  North Carolina,  28805
United States
Recruiting John  Lucke 828-299-2540

Cooper University Hospital *Recruiting*
Camden,  New Jersey,  08103
United States
Recruiting Edison  Catalano 856-342-2506

Palm Beach Cancer Institute *Recruiting*
West Palm Beach,  Florida,  33401
United States
Recruiting Robert  Jacobson 561-366-4150

Florida Hospital Cancer Institute *Recruiting*
Orlando,  Florida,  32804
United States
Recruiting Jane  Crofton 407-303-2090

Veterans Affairs Medical Center - Columbia (Truman Memorial) *Recruiting*
Columbia,  Missouri,  65201
United States
Recruiting William  Patterson 573-882-6163

Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20007
United States
Recruiting Edward  Gelmann 202-444-7303

Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke,  Virginia,  24014
United States
Recruiting Paul  Richards 540-982-0237

UCSF Comprehensive Cancer Center *Recruiting*
San Francisco,  California,  94115
United States
Recruiting Alan  Venook 800-888-8664

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph,  Michigan,  49085
United States
Recruiting Eric  Lester 269-982-4963

Veterans Affairs Medical Center - Durham *Recruiting*
Durham,  North Carolina,  27705
United States
Recruiting Michael  Kelley 919-286-0411

Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla,  California,  92093-0658
United States
Recruiting Stephen  Seagren 858-657-7020

New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City,  New York,  10021
United States
Recruiting Scott  Wadler 212-746-2844


Additional Information:
Study ID Numbers:
  CDR0000334573;  CALGB-30203
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070486

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