Topotecan/Paclitaxel Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study
OBJECTIVES: I. Determine the complete response rate to 2 courses of paclitaxel and topotecan
followed by consolidation chemoradiotherapy in patients with limited stage small cell lung
cancer. II. Determine the toxic effects of this regimen in this patient population. III.
Describe the pattern of relapse, documenting carefully the location of relapse with respect
to the original disease volume and the radiation treatment field in these patients. IV.
Determine the overall and failure free survival of these patients.
OUTLINE: Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1.
Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood
counts recover. The course is repeated once beginning on day 22. After restaging, patients
begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that
radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV
over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every
21 days for a total of 3 courses. Patients with stable or responding disease undergo
prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years,
every 6 months for 3 years, and then at least every year.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 15-18
months.
Interventional
Primary Purpose: Treatment
Alan P. Lyss, MD
Study Chair
Missouri Baptist Cancer Center
United States: Federal Government
CDR0000066958
NCT00003812
March 1999
March 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington, District of Columbia 20007 |
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 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
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 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
University of Illinois at Chicago Health Sciences Center | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - Togus | Togus, Maine 04330 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |