- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00035516
A Phase II Study of Epothilone Analog BMS-247550 in Patients With Non-Small Cell Lung Cancer Who Have Failed First Line Platinum Based Chemotherapy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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California
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Sacramento, California, Estados Unidos, 958177
- Un of California Davis Cancer Center
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Florida
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Miami Beach, Florida, Estados Unidos, 33140
- Mount Sinai Medical Center
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Tampa, Florida, Estados Unidos, 33612
- H Lee Moffitt Cancer Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60612-3828
- Rush Presbyterian St Lukes ME
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- Consultants in Blood Disorders
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Cancer Institute
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland Greenbaum Cancer Center
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Massachusetts
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Burlington, Massachusetts, Estados Unidos, 01805
- Lahey Clinic
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Missouri
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Columbia, Missouri, Estados Unidos, 65203
- University of Missouri/Ellis Fischel Cancer Center
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock /Norris Cotton Cancer Center
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Cancer Institute of New Jersey
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- Unviversity of North Carolina
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Cancer Center
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Nashville, Tennessee, Estados Unidos, 37232-5536
- Vanderbilt University Med School Div of Medical Oncology
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histologically or cytologically confirmed non-small cell lung cancer
- Bidimensionally measurable disease
- Progressed following therapy with one prior cisplatin or carboplatin based chemotherapy regimen for Stage III or IV or metastatic recurrent disease
- Adequate hematologic function as defined by: absolute neutrophils =/> 2,000/mm3, and platelets > 125,000/mm3
- Adequate hepatic function as defined by: serum bilirubin=/<1.5 times the upper institutional limits of normal, ALT =/< 2.5 times the upper institutional limits of normal (=/<5 times the upper institutional limits of normal if hepatic metastases are present
- Adequate renal function as defined: by serum creatine =/< 1.5 times the upper limits of normal
- Adequate recovery from recent surgery, chemotherapy and radiation therapy. At least one week must have elapsed from the time of a minor surgery, at least 3 weeks for major surgery, chemotherapy and radiation therapy
- Life expectancy of at least 12 weeks
- ECOG performance status of 0-1
- At least 18 years old
- Willing and able to give written informed consent
- Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center
- Women of Child Bearing Potential (WOCP) must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of HCG) within 72 hours prior to start of study medication.
WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea=/>12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35mIU/mL]. Even women who are using oral, implanted or, injectable intrauterine device or barrier methods (diaphragm, condoms, spermicide) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
Exclusion Criteria
- More than one prior chemotherapy regimen for Stage IIIB or IV or for metastatic recurrent disease. Prior adjuvant or neoadjuvant chemotherapy is allowed.
- Patients who are candidates for curative resection.
- CTC Grade 2 or greater neuropathy (motor or sensory)
- Known brain metastases
- Prior radiation must have not included major bone marrow containing areas (pelvis, lumbar, spine) and must not have contained a target lesion as the only measurable lesion. A recovery period of at least 3 weeks after completion of radiotherapy is required prior to enrollment.
- Myocardial infarction, unstable angina, or any history of congestive heart failure within six months of study therapy
- Pregnant or breast-feeding women, or sexually active women of childbearing potential not using an adequate method of birth control.
- Sexually active fertile men, whose partners are women of childbearing potential, unless using an adequate method of birth control
- Serious intercurrent infections, or nonmalignant medical illnesses that are controlled or whose control may be jeopardized by the complications of this therapy
- Psychiatric disorders or other conditions rendering the patient incapable of complying with the requirements of the the protocol
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
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
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 no pequeñas
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Epotilonas
Otros números de identificación del estudio
- CA163-011
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. .
Ensayos clínicos sobre Carcinoma de pulmón de células no pequeñas
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Adelphi Values LLCBlueprint Medicines CorporationTerminadoLeucemia de mastocitos (LCM) | Mastocitosis Sistémica Agresiva (ASM) | SM w Asoc Clonal Hema Non-mast Cell Linage Disease (SM-AHNMD) | Mastocitosis sistémica latente (MSS) | Mastocitosis Sistémica Indolente (ISM) Subgrupo ISM Completamente ReclutadoEstados Unidos