Lung Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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)

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT00070486

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 70 Locations for this study

See Locations Near You

Northeast Alabama Regional Medical Center
Anniston Alabama, 36207, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla California, 92093, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
Naval Medical Center - San Diego
San Diego California, 92134, United States
Veterans Affairs Medical Center - San Diego
San Diego California, 92161, United States
UCSF Comprehensive Cancer Center
San Francisco California, 94115, United States
Veterans Affairs Medical Center - San Francisco
San Francisco California, 94121, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Veterans Affairs Medical Center - Washington, DC
Washington District of Columbia, 20422, United States
Broward General Medical Center
Fort Lauderdale Florida, 33316, United States
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood Florida, 33021, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Palm Beach Cancer Institute
West Palm Beach Florida, 33401, United States
MBCCOP - University of Illinois at Chicago
Chicago Illinois, 60612, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Louis A. Weiss Memorial Hospital
Chicago Illinois, 60640, United States
CCOP - Evanston
Evanston Illinois, 60201, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61602, United States
West Suburban Center for Cancer Care
River Forest Illinois, 60305, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne Indiana, 46885, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
Baptist Hospital East - Louisville
Louisville Kentucky, 40207, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore Maryland, 21201, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester Massachusetts, 01655, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph Michigan, 49085, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia Missouri, 65201, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri, 65203, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
Siteman Cancer Center
Saint Louis Missouri, 63110, United States
Missouri Baptist Cancer Center
Saint Louis Missouri, 63131, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas Nevada, 89106, United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett New Hampshire, 03106, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Cooper University Hospital
Camden New Jersey, 08103, United States
Veterans Affairs Medical Center - Buffalo
Buffalo New York, 14215, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse New York, 13057, United States
Queens Cancer Center of Queens Hospital
Jamaica New York, 11432, United States
CCOP - North Shore University Hospital
Manhasset New York, 11030, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
New York Weill Cornell Cancer Center at Cornell University
New York New York, 10021, United States
Mount Sinai Medical Center
New York New York, 10029, United States
University Hospital at State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Veterans Affairs Medical Center - Syracuse
Syracuse New York, 13210, United States
Veterans Affairs Medical Center - Asheville
Asheville North Carolina, 28805, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States
NorthEast Oncology Associates - Concord
Concord North Carolina, 28025, United States
Veterans Affairs Medical Center - Durham
Durham North Carolina, 27705, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Cape Fear Valley Health System
Fayetteville North Carolina, 28302, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro North Carolina, 27534, United States
FirstHealth Moore Regional Hospital
Pinehurst North Carolina, 28374, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington North Carolina, 28402, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Arthur G. James Cancer Hospital at Ohio State University
Columbus Ohio, 43210, United States
Oklahoma University Medical Center
Oklahoma City Oklahoma, 73104, United States
Western Pennsylvania Hospital
Pittsburgh Pennsylvania, 15224, United States
Lifespan: The Miriam Hospital
Providence Rhode Island, 02906, United States
Veterans Affairs Medical Center - Dallas
Dallas Texas, 75219, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas, 75390, United States
Vermont Cancer Center at University of Vermont
Burlington Vermont, 05401, United States
Martha Jefferson Hospital
Charlottesville Virginia, 22902, United States
Virginia Oncology Associates - Norfolk
Norfolk Virginia, 23502, United States
MBCCOP - Massey Cancer Center
Richmond Virginia, 23298, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke Virginia, 24014, United States
St. Mary's Medical Center
Huntington West Virginia, 25701, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT00070486

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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