Single-Agent Versus Combination Chemotherapy in Advanced NSCLC: A CALGB Randomized Trial of Efficacy, Quality of Life, and Cost-Effectiveness
OBJECTIVES: I. Compare the overall survival of patients with non-small cell lung cancer
treated with paclitaxel alone or in combination with carboplatin. II. Compare the quality of
life of these patients treated with these chemotherapy regimens. III. Compare the response
rates and the toxic effects of the two regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to stage of disease
(stage IIIB vs stage IV vs recurrent or progressive after surgery and/or radiotherapy),
performance status (0-1 vs 2), and age (under 70 vs 70 and over). Patients are randomized to
one of two treatment arms. Arm I receives paclitaxel IV over 3 hours on day 1 of each
course. Arm II receives paclitaxel as in Arm I, followed by carboplatin IV over 1 hour.
Treatment is repeated every 21 days for 6 courses in the absence of tumor progression or
unacceptable toxicity. Quality of life assessments are conducted before treatment and at 2,
6, 9, and 12 months. Patients are followed every 3 months for 2 years, then every 6 months
until disease progression or death.
PROJECTED ACCRUAL: This study will accrue 600 patients over 2 years.
Interventional
Primary Purpose: Treatment
Rogerio C. Lilenbaum, MD
Study Chair
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center
United States: Federal Government
CDR0000065871
NCT00003117
October 1997
January 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Massey Cancer Center | Richmond, Virginia 23298-0037 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
North Shore University Hospital | Manhasset, New York 11030 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
University of Illinois at Chicago Health Sciences Center | Chicago, Illinois 60612 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida 33140 |