An Open Label, Multicenter, Randomized, Phase III Comparator Study of Oral Topotecan Versus Intravenous Topotecan for Second Line Therapy in Patients With Small Cell Lung Cancer Who Have Relapsed Greater Than or Equal to 90 Days After Completion of First Line Therapy
OBJECTIVES: I. Compare the response rate, response duration, time to response, time to
progression, and survival of patients with relapsed limited or extensive stage small cell
lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and
quantitative toxicities of these treatment regimens in this patient population. III. Compare
the quality of life in these patients.
OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender,
liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or
less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I:
Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive
topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable
toxicity. Patients experiencing complete or partial response continue until progression or
for at least 2 courses past maximal response. Patients with stable disease should receive at
least 4 courses. Quality of life is assessed Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Nathan Levitan, MD
Study Chair
Case Comprehensive Cancer Center
United States: Federal Government
CDR0000067097
NCT00003917
March 1999
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Cooper Hospital/University Medical Center | Camden, New Jersey 08103 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Baptist Regional Cancer Center - Knoxville | Knoxville, Tennessee 37901 |
Sarah Cannon-Minnie Pearl Cancer Center | Nashville, Tennessee 37203 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Penn State Geisinger Cancer Center | Hershey, Pennsylvania 17033 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
Shands Cancer Center | Gainesville, Florida 32610 |
Baptist Regional Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Evanston Northwestern Health Care | Evanston, Illinois 60201 |
St. Barnabas Medical Center | Livingston, New Jersey 07039 |
Veterans Affairs Medical Center - West Los Angeles | Los Angeles, California 90073 |
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix, Arizona 85012 |
Scripps Clinic | La Jolla, California 92037 |
Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke, Virginia 24014 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Scott and White Memorial Hospital | Temple, Texas 76508 |
Cooper Cancer Institute | Camden, New Jersey 08103 |
Sidney Kimmel Cancer Center | San Diego, California 92121 |
Kaiser Permanente-Southern California Permanente Medical Group | San Diego, California 92120 |
Oncology-Hematology Group of South Florida | Miami, Florida 33176 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Pacific Coast Hematology/Oncology Medical Group | Fountain Valley, California 92708 |
Medical College of Georgia Hospital and Clinics | Augusta, Georgia 30912-3620 |
Brown University Oncology Group | Providence, Rhode Island 02912 |
Louisiana Oncology Associates | Lafayette, Louisiana 70506 |
Rochester General Hospital | Rochester, New York 14621 |
Alton Ochsner Medical Foundation Hospital | New Orleans, Louisiana 70121 |
Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
St. John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Southwest Cancer Care | Poway, California 92064 |
Oncology Clinic, P.C. | Colorado Springs, Colorado 80909 |
Baptist Hospital- Pensacola | Pensacola, Florida 32522 |
Oncology and Hematology Associates, Inc. | Indianapolis, Indiana 46219 |
St. Joseph Mercy Hospital | Pontiac, Michigan 48341-2985 |
Santa Fe Hematology/Oncology | Santa Fe, New Mexico 87505 |
Salem Research | Winston-Salem, North Carolina 27103 |
Central Pennsylvania Hematology & Medical Oncology Associates, PC | Lemoyne, Pennsylvania 17043-1440 |
Spartanburg Regional Healthcare System | Spartanburg, South Carolina 29303 |
Texas Cancer Care | Fort Worth, Texas 76104 |
Joe Arrington Cancer Center | Lubbock, Texas 79410 |
Office of Michael E. Lee | Norfolk, Virginia 23502 |
Hematology & Oncology Associates of Virginia | Richmond, Virginia 23226 |