Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Official Title: A Randomized, Phase III Multicenter Trial Of Gemcitabine In Combination With Carboplatin Or Paclitaxel Plus Carboplatin In Patients With Metastatic (Stage IIIB, IV) Non-Small Cell Lung Cancer
Study ID: NCT00054392
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy such as gemcitabine, carboplatin, and paclitaxel 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. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Detailed Description: OBJECTIVES: * Compare the overall survival of patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with gemcitabine and carboplatin vs gemcitabine and paclitaxel vs paclitaxel and carboplatin. * Compare the overall response rate and time to progression in patients treated with these regimens. * Compare the toxic effects of these regimens in these patients. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss within the past 6 months (less than 5% vs at least 5%), disease stage (IIIB vs IV), and brain metastases (present vs absent). Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 15-30 minutes on day 1. * Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and paclitaxel IV over 3 hours on day 1. * Arm III: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. In all arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 6 weeks during study treatment, and then every 3 months until progressive disease is documented. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 1,134 patients (378 per treatment arm) will be accrued for this study within 2 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States
New Hope Cancer and Research Institute - Pomona, Pomona, California, United States
Lawrence and Memorial Hospital, New London, Connecticut, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center, Lakeland, Florida, United States
Gulf Coast Cancer Treatment Center, Panama City, Florida, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
Cancer Center of Indiana, New Albany, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Annapolis Oncology Center, Annapolis, Maryland, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Greater Baltimore Medical Center Cancer Center, Baltimore, Maryland, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts, United States
Fallon Clinic at Worcester Medical Center, Worcester, Massachusetts, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Sletten Regional Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center, Flemington, New Jersey, United States
, Howell, New Jersey, United States
Jersey Shore Cancer Center at Jersey Shore University Medical Center, Neptune, New Jersey, United States
AtlantiCare Regional Medical Center, Pomona, New Jersey, United States
Mercer Bucks Oncology-Hematology, Trenton, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Cape Fear Valley Medical Center, Fayetteville, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School, Greenville, North Carolina, United States
Aultman Hospital Cancer Center at Aultman Health Foundation, Canton, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Parma Community General Hospital, Parma, Ohio, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania, United States
Falling Spring Medical Associates, Chambersburg, Pennsylvania, United States
Hematology-Oncology Associates of Northeastern Pennsylvania, Dunmore, Pennsylvania, United States
PinnacleHealth Regional Cancer Center at Polyclinic Hospital, Harrisburg, Pennsylvania, United States
Richard G. Laube Cancer Center at ACMH, Kittanning, Pennsylvania, United States
Lancaster Cancer Center, Lancaster, Pennsylvania, United States
Central Pennsylvania Hematology and Medical Oncology Associates, PC, Lemoyne, Pennsylvania, United States
Paoli Hematology-Oncology PC at Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Hahnemann University Hospital, Philadelphia, Pennsylvania, United States
Drexel University College of Medicine - Center City Hahnemann Campus, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center CCOP Research Base, Philadelphia, Pennsylvania, United States
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Pottstown Memorial Regional Cancer Center, Pottstown, Pennsylvania, United States
St. Joseph Medical Center, Reading, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States
South Carolina Oncology Associates, PA, Columbia, South Carolina, United States
Coastal Cancer Center - Myrtle Beach, Myrtle Beach, South Carolina, United States
Family Cancer Center, PLLC - Collierville, Collierville, Tennessee, United States
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee, Knoxville, Tennessee, United States
University of Virginia Cancer Center at UV Health System, Charlottesville, Virginia, United States
David Lee Outpatient Cancer Center at Charleston Area Medical Center, Charleston, West Virginia, United States
Morgantown Internal Medicine Group, Incorporated, Morgantown, West Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown, West Virginia, United States
Contact Details
Name: Joseph A. Treat, MD
Affiliation: Fox Chase Cancer Center
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
