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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
celecoxib
gemcitabine hydrochloride
zileuton
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IV non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Northeast Alabama Regional Medical Center
  • Rebecca and John Moores UCSD Cancer Center
  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
  • Naval Medical Center - San Diego
  • Veterans Affairs Medical Center - San Diego
  • UCSF Comprehensive Cancer Center
  • Veterans Affairs Medical Center - San Francisco
  • CCOP - Christiana Care Health Services
  • Lombardi Cancer Center at Georgetown University Medical Center
  • Walter Reed Army Medical Center
  • Veterans Affairs Medical Center - Washington, DC
  • Broward General Medical Center
  • Memorial Regional Cancer Center at Memorial Regional Hospital
  • CCOP - Mount Sinai Medical Center
  • Palm Beach Cancer Institute
  • MBCCOP - University of Illinois at Chicago
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • CCOP - Evanston
  • CCOP - Illinois Oncology Research Association
  • West Suburban Center for Cancer Care
  • Fort Wayne Medical Oncology and Hematology, Incorporated
  • CCOP - Northern Indiana CR Consortium
  • Holden Comprehensive Cancer Center at University of Iowa
  • Baptist Hospital East - Louisville
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • University of Massachusetts Memorial Medical Center - University Campus
  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
  • Veterans Affairs Medical Center - Minneapolis
  • University of Minnesota Cancer Center
  • Veterans Affairs Medical Center - Columbia (Truman Memorial)
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • CCOP - Kansas City
  • Siteman Cancer Center
  • Missouri Baptist Cancer Center
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • CCOP - Southern Nevada Cancer Research Foundation
  • Veterans Affairs Medical Center - Las Vegas
  • New Hampshire Oncology-Hematology, PA - Hooksett
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Cooper University Hospital
  • Veterans Affairs Medical Center - Buffalo
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • Queens Cancer Center of Queens Hospital
  • CCOP - North Shore University Hospital
  • North Shore University Hospital
  • Memorial Sloan-Kettering Cancer Center
  • New York Weill Cornell Cancer Center at Cornell University
  • Mount Sinai Medical Center
  • University Hospital at State University of New York - Upstate Medical University
  • Veterans Affairs Medical Center - Syracuse
  • Veterans Affairs Medical Center - Asheville
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • NorthEast Oncology Associates - Concord
  • Veterans Affairs Medical Center - Durham
  • Duke Comprehensive Cancer Center
  • Cape Fear Valley Health System
  • CCOP - Southeast Cancer Control Consortium
  • FirstHealth Moore Regional Hospital
  • Zimmer Cancer Center at New Hanover Regional Medical Center
  • Comprehensive Cancer Center at Wake Forest University
  • Arthur G. James Cancer Hospital at Ohio State University
  • Oklahoma University Medical Center
  • Western Pennsylvania Hospital
  • Lifespan: The Miriam Hospital
  • Veterans Affairs Medical Center - Dallas
  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Vermont Cancer Center at University of Vermont
  • Martha Jefferson Hospital
  • Virginia Oncology Associates - Norfolk
  • MBCCOP - Massey Cancer Center
  • Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
  • St. Mary's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Gem + Carboplatin + Zileuton

Gem + Carboplatin + celecoxib

Gem + carboplatin + zilueton + celecoxib

Arm Description

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

Full Information

First Posted
October 3, 2003
Last Updated
June 28, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00070486
Brief Title
Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer
Official Title
Randomized Phase II Study of Eicosanoid Pathway Modulators and Cytotoxic Chemotherapy in Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IV non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gem + Carboplatin + Zileuton
Arm Type
Experimental
Arm Title
Gem + Carboplatin + celecoxib
Arm Type
Experimental
Arm Title
Gem + carboplatin + zilueton + celecoxib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
given IV
Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Description
given PO
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
given IV
Intervention Type
Drug
Intervention Name(s)
zileuton
Intervention Description
given PO
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Edelman, MD
Organizational Affiliation
University of Maryland Greenbaum Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Northeast Alabama Regional Medical Center
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Naval Medical Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134-3202
Country
United States
Facility Name
Veterans Affairs Medical Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Veterans Affairs Medical Center - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Lombardi Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
Veterans Affairs Medical Center - Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Memorial Regional Cancer Center at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
MBCCOP - University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Veterans Affairs Medical Center - Chicago (Westside Hospital)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
West Suburban Center for Cancer Care
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Incorporated
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Baptist Hospital East - Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Veterans Affairs Medical Center - Columbia (Truman Memorial)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Veterans Affairs Medical Center - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
New Hampshire Oncology-Hematology, PA - Hooksett
City
Hooksett
State/Province
New Hampshire
ZIP/Postal Code
03106
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Veterans Affairs Medical Center - Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Queens Cancer Center of Queens Hospital
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University Hospital at State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Asheville
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28805
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
NorthEast Oncology Associates - Concord
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Veterans Affairs Medical Center - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cape Fear Valley Health System
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28302-2000
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
FirstHealth Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Zimmer Cancer Center at New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28402-9025
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Arthur G. James Cancer Hospital at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Lifespan: The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Veterans Affairs Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8852
Country
United States
Facility Name
Vermont Cancer Center at University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
Martha Jefferson Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Virginia Oncology Associates - Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
MBCCOP - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
St. Mary's Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18281656
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

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

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