Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00041314
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind in treating patients who have advanced non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Determine the 18-month survival rate in patients with advanced non-small cell lung cancer treated with carboplatin, gemcitabine, and exisulind.
* Determine the feasibility and toxicity of this regimen in these patients.
* Determine the response rate, progression-free survival, and overall median survival of patients treated with this regimen.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Chemotherapy repeats every 21 days for up to 6 courses. Patients also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until disease progression or unacceptable toxicity occurs.
Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 6 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (79)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Pretoria Academic Hospitals
🇿🇦Pretoria, South Africa
CCOP - Marshfield Medical Research and Education Foundation
🇺🇸Marshfield, Wisconsin, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Veterans Affairs Medical Center - Omaha
🇺🇸Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
MBCCOP-Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Veterans Affairs Medical Center - Gainesville
🇺🇸Gainesville, Florida, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
Evanston Northwestern Health Care
🇺🇸Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Burgess Health Center
🇺🇸Onawa, Iowa, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
MBCCOP-Our Lady of Mercy Cancer Center
🇺🇸Bronx, New York, United States
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Veterans Affairs Medical Center - Brooklyn
🇺🇸Brooklyn, New York, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
Veterans Affairs Medical Center - New York
🇺🇸New York, New York, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Madison
🇺🇸Madison, Wisconsin, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
NSW Breast Cancer Institute
🇦🇺Westmead, New South Wales, Australia
MBCCOP - San Juan
🇵🇷San Juan, Puerto Rico
Veterans Affairs Medical Center - San Juan
🇵🇷San Juan, Puerto Rico
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Palo Alto
🇺🇸Palo Alto, California, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Miami
🇺🇸Miami, Florida, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States