Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Topotecan/Paclitaxel Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and giving them before and with radiation therapy may be an effective treatment for limited-stage small cell lung cancer.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES: I. Determine the complete response rate to 2 courses of paclitaxel and topotecan followed by consolidation chemoradiotherapy in patients with limited stage small cell lung cancer. II. Determine the toxic effects of this regimen in this patient population. III. Describe the pattern of relapse, documenting carefully the location of relapse with respect to the original disease volume and the radiation treatment field in these patients. IV. Determine the overall and failure free survival of these patients.
OUTLINE: Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1. Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover. The course is repeated once beginning on day 22. After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every 21 days for a total of 3 courses. Patients with stable or responding disease undergo prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 15-18 months.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- Veterans Affairs Medical Center - Birmingham
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California
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La Jolla, California, Estados Unidos, 92093-0658
- University of California San Diego Cancer Center
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San Francisco, California, Estados Unidos, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, Estados Unidos, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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Delaware
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Wilmington, Delaware, Estados Unidos, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Estados Unidos, 20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Florida
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Miami Beach, Florida, Estados Unidos, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago Cancer Research Center
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois at Chicago Health Sciences Center
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Hospitals and Clinics
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Maine
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Togus, Maine, Estados Unidos, 04330
- Veterans Affairs Medical Center - Togus
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber Cancer Institute
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Worcester, Massachusetts, Estados Unidos, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55417
- Veterans Affairs Medical Center - Minneapolis
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Missouri
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Columbia, Missouri, Estados Unidos, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, Estados Unidos, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, Estados Unidos, 63110
- Barnes-Jewish Hospital
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Saint Louis, Missouri, Estados Unidos, 63131
- Missouri Baptist Cancer Center
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68198-3330
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, Estados Unidos, 14215
- Veterans Affairs Medical Center - Buffalo
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Manhasset, New York, Estados Unidos, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Estados Unidos, 11030
- North Shore University Hospital
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Estados Unidos, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, Estados Unidos, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, Estados Unidos, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, Estados Unidos, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, Estados Unidos, 13210
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, Estados Unidos, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Estados Unidos, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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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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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38104
- Veterans Affairs Medical Center - Memphis
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Memphis, Tennessee, Estados Unidos, 38163
- University of Tennessee, Memphis Cancer Center
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Vermont
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Burlington, Vermont, Estados Unidos, 05401-3498
- Vermont Cancer Center
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White River Junction, Vermont, Estados Unidos, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Richmond, Virginia, Estados Unidos, 23298-0037
- MBCCOP - Massey Cancer Center
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Richmond, Virginia, Estados Unidos, 23249
- Veterans Affairs Medical Center - Richmond
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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 stage small cell lung cancer Includes disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal lymph nodes Clinically suspected or confirmed supraclavicular lymph node metastases and pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are not eligible Unidimensionally or bidimensionally measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than ULN Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent active second malignancy except nonmelanoma skin cancer (i.e., completed therapy and considered to be at less than 30% risk of relapse)
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No concurrent steroids except for adrenal failure No concurrent hormones except for nondisease related conditions (e.g., insulin for diabetes) No concurrent dexamethasone except for intermittent use as an antiemetic or as an adjunct to prophylactic cranial irradiation Radiotherapy: No prior mediastinal radiotherapy Surgery: Not specified
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: chemotherapy + radiation therapy
Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1.
Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover.
The course is repeated once beginning on day 22.
After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks.
On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45).
The consolidation chemotherapy is repeated every 21 days for a total of 3 courses.
Patients with stable or responding disease undergo prophylactic cranial irradiation.
Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Tasa de respuesta
Periodo de tiempo: Hasta 5 años
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Hasta 5 años
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sobrevivencia promedio
Periodo de tiempo: Hasta 5 años
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Hasta 5 años
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Alan P. Lyss, MD, Missouri Baptist Cancer Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Bogart JA, Herndon JE 2nd, Lyss AP, Watson D, Miller AA, Lee ME, Turrisi AT, Green MR; Cancer and Leukemia Group B study 39808. 70 Gy thoracic radiotherapy is feasible concurrent with chemotherapy for limited-stage small-cell lung cancer: analysis of Cancer and Leukemia Group B study 39808. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):460-8. doi: 10.1016/j.ijrobp.2003.10.021.
- Cicchetti MG, Bogart J, Lyss A, et al.: Spinal cord dose in limited stage small cell lung cancer: a preliminary Quality Assurance Review Committee (QARC) report on CALGB 39808, using target thoracic radiotherapy (TRT) doses of 60 - 70 Gy. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-656, 356, 2001.
- Lyss AP, Herndon JE, Bogart JE, et al.: Topotecan (Topo) + paclitaxel (Tax) + G-CSF (G) induction followed by concurrent chemoradiotherapy (CCRT) for patients (pts) with limited stage small cell lung cancer (L-SCLC): preliminary analysis of CALGB 39808. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1270, 2001.
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
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Inhibidores de la topoisomerasa I
- Carboplatino
- Etopósido
- Paclitaxel
- Topotecán
Otros números de identificación del estudio
- CALGB-39808
- U10CA031946 (Subvención/contrato del NIH de EE. UU.)
- CLB-39808
- CDR0000066958 (Identificador de registro: NCI Physician Data Query)
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