- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00003917
Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
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
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- University of Alabama Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Förenta staterna, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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California
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Bakersfield, California, Förenta staterna, 93309
- Comprehensive Blood and Cancer Center
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Fountain Valley, California, Förenta staterna, 92708
- Pacific Coast Hematology/Oncology Medical Group
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La Jolla, California, Förenta staterna, 92037
- Scripps Clinic
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Los Angeles, California, Förenta staterna, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Poway, California, Förenta staterna, 92064
- Southwest Cancer Care
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Sacramento, California, Förenta staterna, 95817
- University of California Davis Cancer Center
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San Diego, California, Förenta staterna, 92120
- Kaiser Permanente-Southern California Permanente Medical Group
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San Diego, California, Förenta staterna, 92121
- Sidney Kimmel Cancer Center
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80909
- Oncology Clinic, P.C.
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Florida
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Gainesville, Florida, Förenta staterna, 32610
- Shands Cancer Center
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Jacksonville, Florida, Förenta staterna, 32207
- Baptist Regional Cancer Institute - Jacksonville
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Miami, Florida, Förenta staterna, 33176
- Oncology-Hematology Group of South Florida
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Pensacola, Florida, Förenta staterna, 32522
- Baptist Hospital- Pensacola
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Tampa, Florida, Förenta staterna, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Augusta, Georgia, Förenta staterna, 30912-3620
- Medical College of Georgia Hospital and Clinics
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Illinois
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Evanston, Illinois, Förenta staterna, 60201
- Evanston Northwestern Health Care
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Hines, Illinois, Förenta staterna, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46219
- Oncology and Hematology Associates, Inc.
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Louisiana
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Lafayette, Louisiana, Förenta staterna, 70506
- Louisiana Oncology Associates
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New Orleans, Louisiana, Förenta staterna, 70121
- Alton Ochsner Medical Foundation Hospital
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Michigan
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Hospital
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Pontiac, Michigan, Förenta staterna, 48341-2985
- St. Joseph Mercy Hospital
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Minnesota
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- CCOP - Metro-Minnesota
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63141
- St. John's Mercy Medical Center
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New Jersey
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Camden, New Jersey, Förenta staterna, 08103
- Cooper Cancer Institute
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Livingston, New Jersey, Förenta staterna, 07039
- St. Barnabas Medical Center
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Voorhees, New Jersey, Förenta staterna, 08043
- Cooper Hospital/University Medical Center
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New Mexico
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Santa Fe, New Mexico, Förenta staterna, 87505
- Santa Fe Hematology/Oncology
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New York
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Rochester, New York, Förenta staterna, 14621
- Rochester General Hospital
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Syracuse, New York, Förenta staterna, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Winston-Salem, North Carolina, Förenta staterna, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Winston-Salem, North Carolina, Förenta staterna, 27103
- Salem Research
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106-5065
- Ireland Cancer Center
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Pennsylvania
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Hershey, Pennsylvania, Förenta staterna, 17033
- Penn State Geisinger Cancer Center
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Lemoyne, Pennsylvania, Förenta staterna, 17043-1440
- Central Pennsylvania Hematology & Medical Oncology Associates, PC
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University of Pittsburgh Cancer Institute
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Reading, Pennsylvania, Förenta staterna, 19612-6052
- Reading Hospital and Medical Center
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02912
- Brown University Oncology Group
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South Carolina
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Greenville, South Carolina, Förenta staterna, 29605
- Cancer Centers of the Carolinas
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Spartanburg, South Carolina, Förenta staterna, 29303
- Spartanburg Regional Healthcare System
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Tennessee
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Knoxville, Tennessee, Förenta staterna, 37901
- Baptist Regional Cancer Center - Knoxville
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Nashville, Tennessee, Förenta staterna, 37203
- Sarah Cannon-Minnie Pearl Cancer Center
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Texas
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Fort Worth, Texas, Förenta staterna, 76104
- Texas Cancer Care
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Galveston, Texas, Förenta staterna, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Förenta staterna, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lubbock, Texas, Förenta staterna, 79410
- Joe Arrington Cancer Center
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Temple, Texas, Förenta staterna, 76508
- Scott and White Memorial Hospital
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Virginia
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Norfolk, Virginia, Förenta staterna, 23502
- Office of Michael E. Lee
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Richmond, Virginia, Förenta staterna, 23226
- Hematology & Oncology Associates of Virginia
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Roanoke, Virginia, Förenta staterna, 24014
- Oncology and Hematology Associates of Southwest Virginia, Inc.
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Wisconsin
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Waukesha, Wisconsin, Förenta staterna, 53188
- Waukesha Memorial Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited or extensive stage small cell lung cancer (SCLC) Disease recurring at least 90 days following completion of first line chemotherapy Partial or complete response to first line therapy Must have at least one bidimensionally measurable non CNS lesion May be within a prior radiation port if at least 6 weeks since prior radiotherapy and progressing Brain and/or leptomeningeal metastases allowed if asymptomatic and not requiring corticosteroids
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Nathan Levitan, MD, Case Comprehensive Cancer Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Småcelligt lungkarcinom
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Topoisomerasinhibitorer
- Topoisomeras I-hämmare
- Topotecan
Andra studie-ID-nummer
- SKF1598
- CWRU-SKF-1598
- SB-104864-A/396
- NCI-G99-1524
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