- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00070486
Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer
Randomized Phase II Study of Eicosanoid Pathway Modulators and Cytotoxic Chemotherapy in Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in 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: Randomized phase 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Anniston, Alabama, United States, 36207
- Northeast Alabama Regional Medical Center
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California
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La Jolla, California, United States, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Los Angeles, California, United States, 90048
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
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San Diego, California, United States, 92161
- Veterans Affairs Medical Center - San Diego
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San Diego, California, United States, 92134-3202
- Naval Medical Center - San Diego
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San Francisco, California, United States, 94115
- UCSF Comprehensive Cancer Center
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San Francisco, California, United States, 94121
- Veterans Affairs Medical Center - San Francisco
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Delaware
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Newark, Delaware, United States, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20422
- Veterans Affairs Medical Center - Washington, DC
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Washington, District of Columbia, United States, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, United States, 20307-5001
- Walter Reed Army Medical Center
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Broward General Medical Center
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Hollywood, Florida, United States, 33021
- Memorial Regional Cancer Center at Memorial Regional Hospital
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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West Palm Beach, Florida, United States, 33401
- Palm Beach Cancer Institute
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Illinois
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Chicago, Illinois, United States, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, United States, 60640
- Louis A. Weiss Memorial Hospital
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Chicago, Illinois, United States, 60612
- MBCCOP - University of Illinois at Chicago
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Evanston, Illinois, United States, 60201
- CCOP - Evanston
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Peoria, Illinois, United States, 61602
- CCOP - Illinois Oncology Research Association
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River Forest, Illinois, United States, 60305
- West Suburban Center for Cancer Care
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Indiana
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Fort Wayne, Indiana, United States, 46885-5099
- Fort Wayne Medical Oncology and Hematology, Incorporated
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South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Louisville, Kentucky, United States, 40207
- Baptist Hospital East - Louisville
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Maryland
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Baltimore, Maryland, United States, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Memorial Medical Center - University Campus
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Michigan
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Saint Joseph, Michigan, United States, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, United States, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, United States, 63110
- Siteman Cancer Center
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Saint Louis, Missouri, United States, 63131
- Missouri Baptist Cancer Center
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Nebraska
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Omaha, Nebraska, United States, 68198-7680
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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Las Vegas, Nevada, United States, 89106
- Veterans Affairs Medical Center - Las Vegas
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New Hampshire
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Hooksett, New Hampshire, United States, 03106
- New Hampshire Oncology-Hematology, PA - Hooksett
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper University Hospital
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New York
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Buffalo, New York, United States, 14215
- Veterans Affairs Medical Center - Buffalo
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East Syracuse, New York, United States, 13057
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Jamaica, New York, United States, 11432
- Queens Cancer Center of Queens Hospital
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Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, United States, 10029
- Mount Sinai Medical Center
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Syracuse, New York, United States, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, United States, 13210
- University Hospital at State University of New York - Upstate Medical University
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North Carolina
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Asheville, North Carolina, United States, 28805
- Veterans Affairs Medical Center - Asheville
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Concord, North Carolina, United States, 28025
- NorthEast Oncology Associates - Concord
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Durham, North Carolina, United States, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Fayetteville, North Carolina, United States, 28302-2000
- Cape Fear Valley Health System
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Goldsboro, North Carolina, United States, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Pinehurst, North Carolina, United States, 28374
- Firsthealth Moore Regional Hospital
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Wilmington, North Carolina, United States, 28402-9025
- Zimmer Cancer Center at New Hanover Regional Medical Center
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital at Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma University Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Western Pennsylvania Hospital
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Lifespan: The Miriam Hospital
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Texas
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Dallas, Texas, United States, 75219
- Veterans Affairs Medical Center - Dallas
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Dallas, Texas, United States, 75390-8852
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Vermont
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Burlington, Vermont, United States, 05401-3498
- Vermont Cancer Center at University of Vermont
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Virginia
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Charlottesville, Virginia, United States, 22902
- Martha Jefferson Hospital
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Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates - Norfolk
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Richmond, Virginia, United States, 23298-0037
- MBCCOP - Massey Cancer Center
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Roanoke, Virginia, United States, 24014
- Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
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West Virginia
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Huntington, West Virginia, United States, 25701
- St. Mary's Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
At least 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs), including any of the following:
- Rofecoxib
- Choline magnesium trisalicylate
- Ibuprofen
- Naproxen
- Etodolac
- Oxaprozin
- Diflunisal
- Nabumetone
- Tolmetin
- Valdecoxib
- No concurrent NSAIDs
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gem + Carboplatin + Zileuton
|
given IV
given IV
given PO
|
Experimental: Gem + Carboplatin + celecoxib
|
given IV
given IV
given PO
|
Experimental: Gem + carboplatin + zilueton + celecoxib
|
given IV
given IV
given PO
given PO
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease free survival
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Martin Edelman, MD, University of Maryland Greenbaum Cancer Center
Publications and helpful links
General Publications
- Edelman MJ, Watson D, Wang X, Morrison C, Kratzke RA, Jewell S, Hodgson L, Mauer AM, Gajra A, Masters GA, Bedor M, Vokes EE, Green MJ. Eicosanoid modulation in advanced lung cancer: cyclooxygenase-2 expression is a positive predictive factor for celecoxib + chemotherapy--Cancer and Leukemia Group B Trial 30203. J Clin Oncol. 2008 Feb 20;26(6):848-55. doi: 10.1200/JCO.2007.13.8081.
- Edelman, MJ, Watson DM, Wang X, et al.: Eicosanoid modulation in advanced non-small cell lung cancer (NSCLC): CALGB 30203. [Abstract] J Clin Oncol 24 (Suppl 18): A-7025, 370s, 2006.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Leukotriene Antagonists
- Hormone Antagonists
- Cyclooxygenase 2 Inhibitors
- Lipoxygenase Inhibitors
- Gemcitabine
- Carboplatin
- Celecoxib
- Zileuton
Other Study ID Numbers
- CALGB-30203
- U10CA031946 (U.S. NIH Grant/Contract)
- CDR0000334573 (Registry Identifier: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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