- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Estados Unidos, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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California
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Bakersfield, California, Estados Unidos, 93309
- Comprehensive Blood and Cancer Center
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Fountain Valley, California, Estados Unidos, 92708
- Pacific Coast Hematology/Oncology Medical Group
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La Jolla, California, Estados Unidos, 92037
- Scripps Clinic
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Los Angeles, California, Estados Unidos, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Poway, California, Estados Unidos, 92064
- Southwest Cancer Care
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Sacramento, California, Estados Unidos, 95817
- University of California Davis Cancer Center
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San Diego, California, Estados Unidos, 92120
- Kaiser Permanente-Southern California Permanente Medical Group
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San Diego, California, Estados Unidos, 92121
- Sidney Kimmel Cancer Center
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80909
- Oncology Clinic, P.C.
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Florida
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Gainesville, Florida, Estados Unidos, 32610
- Shands Cancer Center
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Jacksonville, Florida, Estados Unidos, 32207
- Baptist Regional Cancer Institute - Jacksonville
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Miami, Florida, Estados Unidos, 33176
- Oncology-Hematology Group of South Florida
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Pensacola, Florida, Estados Unidos, 32522
- Baptist Hospital- Pensacola
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Tampa, Florida, Estados Unidos, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Augusta, Georgia, Estados Unidos, 30912-3620
- Medical College of Georgia Hospital and Clinics
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Illinois
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Evanston, Illinois, Estados Unidos, 60201
- Evanston Northwestern Health Care
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Hines, Illinois, Estados Unidos, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46219
- Oncology and Hematology Associates, Inc.
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Louisiana
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Lafayette, Louisiana, Estados Unidos, 70506
- Louisiana Oncology Associates
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New Orleans, Louisiana, Estados Unidos, 70121
- Alton Ochsner Medical Foundation Hospital
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
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Pontiac, Michigan, Estados Unidos, 48341-2985
- St. Joseph Mercy Hospital
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Minnesota
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63141
- St. John's Mercy Medical Center
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103
- Cooper Cancer Institute
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Livingston, New Jersey, Estados Unidos, 07039
- St. Barnabas Medical Center
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Voorhees, New Jersey, Estados Unidos, 08043
- Cooper Hospital/University Medical Center
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New Mexico
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Santa Fe, New Mexico, Estados Unidos, 87505
- Santa Fe Hematology/Oncology
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New York
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Rochester, New York, Estados Unidos, 14621
- Rochester General Hospital
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Syracuse, New York, Estados Unidos, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Salem Research
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106-5065
- Ireland Cancer Center
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Geisinger Cancer Center
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Lemoyne, Pennsylvania, Estados Unidos, 17043-1440
- Central Pennsylvania Hematology & Medical Oncology Associates, PC
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Cancer Institute
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Reading, Pennsylvania, Estados Unidos, 19612-6052
- Reading Hospital and Medical Center
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02912
- Brown University Oncology Group
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29605
- Cancer Centers of the Carolinas
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Spartanburg, South Carolina, Estados Unidos, 29303
- Spartanburg Regional Healthcare System
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37901
- Baptist Regional Cancer Center - Knoxville
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon-Minnie Pearl Cancer Center
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Texas
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Fort Worth, Texas, Estados Unidos, 76104
- Texas Cancer Care
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Galveston, Texas, Estados Unidos, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Estados Unidos, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lubbock, Texas, Estados Unidos, 79410
- Joe Arrington Cancer Center
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Temple, Texas, Estados Unidos, 76508
- Scott and White Memorial Hospital
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
- Office of Michael E. Lee
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Richmond, Virginia, Estados Unidos, 23226
- Hematology & Oncology Associates of Virginia
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Roanoke, Virginia, Estados Unidos, 24014
- Oncology and Hematology Associates of Southwest Virginia, Inc.
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Wisconsin
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Waukesha, Wisconsin, Estados Unidos, 53188
- Waukesha Memorial Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Nathan Levitan, MD, Case Comprehensive Cancer Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células pequeñas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la topoisomerasa
- Inhibidores de la topoisomerasa I
- Topotecán
Otros números de identificación del estudio
- SKF1598
- CWRU-SKF-1598
- SB-104864-A/396
- NCI-G99-1524
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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