Combination Chemotherapy and Exisulind in Treating Patients With Extensive-Stage Small Cell Lung Cancer
- Registration Number
- NCT00041054
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Exisulind may make tumor cells more sensitive to chemotherapy. Combining chemotherapy with exisulind may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with exisulind in treating patients who have extensive-stage small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Determine the percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment with carboplatin, etoposide, and exisulind.
* Determine the response rate of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 4 months for 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description carboplatin + etoposide + exisulind exisulind Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 4 months for 2 years. carboplatin + etoposide + exisulind carboplatin Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 4 months for 2 years. carboplatin + etoposide + exisulind etoposide Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 4 months for 2 years.
- Primary Outcome Measures
Name Time Method percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment Up to 3 years
- Secondary Outcome Measures
Name Time Method response rate Up to 3 years
Trial Locations
- Locations (83)
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Veterans Affairs Medical Center - Baltimore
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Lenoir Memorial Hospital Cancer Center
🇺🇸Kinston, North Carolina, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Memorial Regional Hospital Comprehensive Cancer Center
🇺🇸Hollywood, Florida, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
🇺🇸West Palm Beach, Florida, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Saint Anthony Medical Center
🇺🇸Rockford, Illinois, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Hematology Oncology Associates of the Quad Cities
🇺🇸Bettendorf, Iowa, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Lakeland Medical Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Veterans Affairs Medical Center - Fargo
🇺🇸Fargo, North Dakota, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Ministry Medical Group - Northern Region
🇺🇸Rhinelander, Wisconsin, United States
McGill University
🇨🇦Montreal, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
NorthEast Oncology Associates
🇺🇸Concord, North Carolina, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
🇺🇸Roanoke, Virginia, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States