Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00003917
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if topotecan is more effective given by infusion or by mouth.
PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (53)
Spartanburg Regional Healthcare System
🇺🇸Spartanburg, South Carolina, United States
Veterans Affairs Medical Center - West Los Angeles
🇺🇸Los Angeles, California, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
Baptist Hospital- Pensacola
🇺🇸Pensacola, Florida, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
Oncology Clinic, P.C.
🇺🇸Colorado Springs, Colorado, United States
Pacific Coast Hematology/Oncology Medical Group
🇺🇸Fountain Valley, California, United States
Oncology-Hematology Group of South Florida
🇺🇸Miami, Florida, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Cooper Cancer Institute
🇺🇸Camden, New Jersey, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
St. Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Baptist Regional Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Brown University Oncology Group
🇺🇸Providence, Rhode Island, United States
Joe Arrington Cancer Center
🇺🇸Lubbock, Texas, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Cancer Care
🇺🇸Fort Worth, Texas, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Penn State Geisinger Cancer Center
🇺🇸Hershey, Pennsylvania, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
🇺🇸Roanoke, Virginia, United States
Oncology and Hematology Associates, Inc.
🇺🇸Indianapolis, Indiana, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Kaiser Permanente-Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
🇺🇸Phoenix, Arizona, United States
Sidney Kimmel Cancer Center
🇺🇸San Diego, California, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Sarah Cannon-Minnie Pearl Cancer Center
🇺🇸Nashville, Tennessee, United States
Southwest Cancer Care
🇺🇸Poway, California, United States
Medical College of Georgia Hospital and Clinics
🇺🇸Augusta, Georgia, United States
Evanston Northwestern Health Care
🇺🇸Evanston, Illinois, United States
Louisiana Oncology Associates
🇺🇸Lafayette, Louisiana, United States
St. Joseph Mercy Hospital
🇺🇸Pontiac, Michigan, United States
Cooper Hospital/University Medical Center
🇺🇸Voorhees, New Jersey, United States
St. John's Mercy Medical Center
🇺🇸Saint Louis, Missouri, United States
Santa Fe Hematology/Oncology
🇺🇸Santa Fe, New Mexico, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Central Pennsylvania Hematology & Medical Oncology Associates, PC
🇺🇸Lemoyne, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Baptist Regional Cancer Center - Knoxville
🇺🇸Knoxville, Tennessee, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Office of Michael E. Lee
🇺🇸Norfolk, Virginia, United States
Scott and White Memorial Hospital
🇺🇸Temple, Texas, United States
Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Salem Research
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Alton Ochsner Medical Foundation Hospital
🇺🇸New Orleans, Louisiana, United States
Hematology & Oncology Associates of Virginia
🇺🇸Richmond, Virginia, United States