Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00070486
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gem + Carboplatin + celecoxib gemcitabine hydrochloride - Gem + Carboplatin + Zileuton gemcitabine hydrochloride - Gem + Carboplatin + celecoxib celecoxib - Gem + carboplatin + zilueton + celecoxib gemcitabine hydrochloride - Gem + Carboplatin + Zileuton carboplatin - Gem + Carboplatin + celecoxib carboplatin - Gem + Carboplatin + Zileuton zileuton - Gem + carboplatin + zilueton + celecoxib carboplatin - Gem + carboplatin + zilueton + celecoxib celecoxib - Gem + carboplatin + zilueton + celecoxib zileuton -
- Primary Outcome Measures
Name Time Method Disease free survival 9 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (75)
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Arthur G. James Cancer Hospital at Ohio State University
🇺🇸Columbus, Ohio, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Memorial Regional Cancer Center at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Palm Beach Cancer Institute
🇺🇸West Palm Beach, Florida, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett
🇺🇸Hooksett, New Hampshire, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸East Syracuse, New York, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
University Hospital at State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
NorthEast Oncology Associates - Concord
🇺🇸Concord, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
🇺🇸Roanoke, Virginia, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States