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
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Survival
No
Joseph A. Treat, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000270434
NCT00054392
September 2001
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Drexel University College of Medicine - Center City Hahnemann Campus | Philadelphia, Pennsylvania 19102 |
Gulf Coast Cancer Treatment Center | Panama City, Florida 32405-4587 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia 26506 |
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
Parma Community General Hospital | Parma, Ohio 44129 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Cape Fear Valley Medical Center | Fayetteville, North Carolina 28302-2000 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland, Florida 33805 |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee | Knoxville, Tennessee 37901 |
Lawrence and Memorial Hospital | New London, Connecticut 06320 |
Pottstown Memorial Regional Cancer Center | Pottstown, Pennsylvania 19464 |
Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
St. Joseph Medical Center | Reading, Pennsylvania 19604 |
Greater Baltimore Medical Center Cancer Center | Baltimore, Maryland 21204 |
Leo W. Jenkins Cancer Center at ECU Medical School | Greenville, North Carolina 27834 |
Fox Chase Cancer Center CCOP Research Base | Philadelphia, Pennsylvania 19140 |
Fallon Clinic at Worcester Medical Center | Worcester, Massachusetts 01608 |
AtlantiCare Regional Medical Center | Pomona, New Jersey 08240 |
Central Pennsylvania Hematology and Medical Oncology Associates, PC | Lemoyne, Pennsylvania 17043 |
University of Virginia Cancer Center at UV Health System | Charlottesville, Virginia 22908 |
Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
PinnacleHealth Regional Cancer Center at Polyclinic Hospital | Harrisburg, Pennsylvania 17105 |
South Carolina Oncology Associates, PA | Columbia, South Carolina 29210 |
Hackensack, New Jersey 07601 | |
Lancaster Cancer Center | Lancaster, Pennsylvania 17604 |
Jersey Shore Cancer Center at Jersey Shore University Medical Center | Neptune, New Jersey 07754-0397 |
New Hope Cancer and Research Institute - Pomona | Pomona, California 91767 |
Cancer Center of Indiana | New Albany, Indiana 47150 |
Annapolis Oncology Center | Annapolis, Maryland 21401 |
Mercer Bucks Oncology-Hematology | Trenton, New Jersey 08618 |
Falling Spring Medical Associates | Chambersburg, Pennsylvania 17201 |
Hematology-Oncology Associates of Northeastern Pennsylvania | Dunmore, Pennsylvania 18512 |
Richard G. Laube Cancer Center at ACMH | Kittanning, Pennsylvania 16201 |
Paoli Hematology-Oncology PC at Paoli Memorial Hospital | Paoli, Pennsylvania 19301 |
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia | Philadelphia, Pennsylvania 19106 |
Coastal Cancer Center - Myrtle Beach | Myrtle Beach, South Carolina 29572 |
Family Cancer Center, PLLC - Collierville | Collierville, Tennessee 38077 |
David Lee Outpatient Cancer Center at Charleston Area Medical Center | Charleston, West Virginia 25304-1297 |
Morgantown Internal Medicine Group, Incorporated | Morgantown, West Virginia 26505 |