Paclitaxel/Topotecan/Etoposide (EtopoTax) Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study
OBJECTIVES:
- Determine the complete and overall response rates in patients with limited stage small
cell lung cancer treated with induction chemotherapy comprising paclitaxel, topotecan,
and etoposide followed by consolidation chemoradiotherapy.
- Determine the toxicity of this regimen in these patients.
- Determine the overall and failure-free survival of patients treated with this regimen.
- Determine the overall (partial and complete) response rate in patients treated with
this induction chemotherapy regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral
topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients
also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and
continuing until blood counts recover.
- Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and
85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo
radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks.
Patients with rapid disease progression discontinue study therapy.
Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and
then annually for 5 years.
PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 10
months.
Interventional
Primary Purpose: Treatment
Antonius A. Miller, MD
Study Chair
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
CDR0000069313
NCT00033696
September 2001
April 2009
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 Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
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 |
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 |
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 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
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 |
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
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 |
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 |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |