Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
NCT ID: NCT00003917
Last Updated: 2014-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
4 participants
INTERVENTIONAL
1999-03-31
2001-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
Interventions
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topotecan hydrochloride
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (after transfusion, if needed) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active uncontrolled infection No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical conditions that would preclude study or cause exposure to extreme risk or decreased life expectancy No uncontrolled emesis No active peptic ulcer, diabetes mellitus, chronic gastritis, significant ascites, or other gastrointestinal (GI) conditions (e.g., removal of a portion of the stomach or recent GI obstruction) that would alter absorption or GI motility No history of allergic reactions to compounds chemically related to topotecan Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months prior to, during, and at least 4 weeks after the study
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent immunotherapy for SCLC Chemotherapy: See Disease Characteristics No prior topotecan Only one prior chemotherapy regimen allowed No other concurrent chemotherapy for SCLC Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 24 hours since prior radiotherapy No concurrent radiotherapy for SCLC Surgery: At least 4 weeks since prior surgery Other: At least 30 days or five half lives since other prior investigational drugs No prior drugs (e.g., cisapride) that would alter absorption or GI motility No other concurrent investigational therapy for SCLC
18 Years
ALL
No
Sponsors
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Smith Kline Beecham
UNKNOWN
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nathan Levitan, MD
Role: STUDY_CHAIR
Case Comprehensive Cancer Center
Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, United States
Scripps Clinic
La Jolla, California, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States
Southwest Cancer Care
Poway, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States
Sidney Kimmel Cancer Center
San Diego, California, United States
Oncology Clinic, P.C.
Colorado Springs, Colorado, United States
Shands Cancer Center
Gainesville, Florida, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Oncology-Hematology Group of South Florida
Miami, Florida, United States
Baptist Hospital- Pensacola
Pensacola, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Medical College of Georgia Hospital and Clinics
Augusta, Georgia, United States
Evanston Northwestern Health Care
Evanston, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States
Oncology and Hematology Associates, Inc.
Indianapolis, Indiana, United States
Louisiana Oncology Associates
Lafayette, Louisiana, United States
Alton Ochsner Medical Foundation Hospital
New Orleans, Louisiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Joseph Mercy Hospital
Pontiac, Michigan, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
Cooper Cancer Institute
Camden, New Jersey, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
Cooper Hospital/University Medical Center
Voorhees Township, New Jersey, United States
Santa Fe Hematology/Oncology
Santa Fe, New Mexico, United States
Rochester General Hospital
Rochester, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, 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
Ireland Cancer Center
Cleveland, Ohio, United States
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, United States
Central Pennsylvania Hematology & Medical Oncology Associates, PC
Lemoyne, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Brown University Oncology Group
Providence, Rhode Island, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, United States
Texas Cancer Care
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Joe Arrington Cancer Center
Lubbock, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Office of Michael E. Lee
Norfolk, Virginia, United States
Hematology & Oncology Associates of Virginia
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Countries
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References
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Eckardt JR, von Pawel J, Pujol JL, Papai Z, Quoix E, Ardizzoni A, Poulin R, Preston AJ, Dane G, Ross G. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol. 2007 May 20;25(15):2086-92. doi: 10.1200/JCO.2006.08.3998.
Other Identifiers
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CWRU-SKF-1598
Identifier Type: -
Identifier Source: secondary_id
SB-104864-A/396
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1524
Identifier Type: -
Identifier Source: secondary_id
SKF1598
Identifier Type: -
Identifier Source: org_study_id
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