- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00030706
Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Phase II Study Of Epothilone B Analogue BMS-247550 In Relapse And/Or Refractory Stage III Or IV Ovarian Epithelial Cancer, Following Front-Line Treatment With Platinum Plus Taxane-Based Chemotherapy
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed and/or refractory stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the antitumor activity of ixabepilone, in terms of clinical response and progression-free survival, in patients with relapsed and/or refractory stage III or IV ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this drug in these patients.
Secondary
- Correlate pre-ixabepilone survivin mRNA and protein levels in patient-derived ovarian cancer cells with quality of response (i.e., at least partial response vs no response).
- Correlate CYP3A4 (3A4*1B), 3A5 (3A5*1), and 3A7 (ER6 p variation) allelic polymorphisms with parent drug kinetic parameters, toxicity, and efficacy of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive ixabepilone IV over 1 hour once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
Bronx, New York, Estados Unidos, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
-
-
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 stage III or IV ovarian epithelial cancer or primary peritoneal carcinoma
Recurrent or refractory disease
- Previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel
- Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
Bidimensionally measurable disease by physical exam, CT scan, or MRI
- Ascites and pleural effusions are not measurable disease
- No prior irradiation to indicator lesions
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No prior bleeding disorder or unexplained bleeding
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT/SGPT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 times ULN
Other
- No active infection requiring antibiotics
- No grade 2 or greater neuropathy (sensory and motor)
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No prior recurrent grade 2 or greater hypersensitivity reactions to Cremophor EL, docetaxel, or paclitaxel
- No other medical condition that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 weeks since prior biologic or immunologic therapy for ovarian epithelial or primary peritoneal carcinoma
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy and recovered
- No prior ixabepilone
- No prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma
Endocrine therapy
- At least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma
- Concurrent hormonal replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- No prior radiotherapy to a site of measurable disease used on study
- No prior radiotherapy to more than 25% of bone marrow
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Other
- At least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma
- No prior cancer treatment for other invasive malignancies that would preclude study participation
- No concurrent heparin or other anticoagulants
- No concurrent Hypericum perforatum (St. John's wort) or any product containing this compound
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)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of clinical remission
Periodo de tiempo: up to 12-months post-treatment
|
number of participants experience clinical remission will be determined
|
up to 12-months post-treatment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gary L. Goldberg, MD, Albert Einstein College Of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (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 (Actual)
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
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias urogenitales
- Neoplasias por sitio
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias Genitales Femeninas
- Enfermedades del sistema endocrino
- Enfermedades Ováricas
- Enfermedades anexiales
- Trastornos gonadales
- Neoplasias de glándulas endocrinas
- Neoplasias Ováricas
- Carcinoma Epitelial De Ovario
Otros números de identificación del estudio
- CDR0000069190
- P30CA013330 (Subvención/contrato del NIH de EE. UU.)
- AECM-3632
- MCC-12602
- NCI-3632
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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 Cáncer de ovarios
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
-
Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos
-
Rabin Medical CenterReclutamiento