- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00504257
Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma
A Phase II Trial of Avastin in Combination With Docetaxel in Patients With Recurrence of Epithelial Carcinoma of the Ovary/Fallopian Tube/Peritoneum Within 12 Months of Platinum Therapy
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Fort Lauderdale, Florida, Estados Unidos, 33316
- Broward General Medical Center Cancer Center
-
Saint Petersburg, Florida, Estados Unidos, 33701
- Women's Cancer Associates
-
Tampa, Florida, Estados Unidos, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
-
North Carolina
-
Durham, North Carolina, Estados Unidos, 27710
- Duke Cancer Institute
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Signed informed consent
- Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or fallopian tube cancer
- Patient's disease recurrence or progression occurs between 0 to 12 months (1 to 365 days) from prior platinum-containing chemotherapy regimen. Patients, however, may not receive study drug until at least 28 days from prior chemotherapy.
- The patient may have received up to three prior chemotherapy regimens for the treatment of this malignancy. Patients who may have received prior treatment with paclitaxel and/or a platinum compound will be allowed. Rechallenge with the same platinum based regimen is considered 1 prior regimen. Patients who have been treated with consolidation treatment are allowed and the consolidation will not be considered a separate regimen. Hormonal therapy (i.e. progesterones, estrogens, anti-estrogens, aromatase inhibitors) will not be considered a prior chemotherapy regimen.
- Measurable or evaluable disease either by the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) or cancer antigen (CA)125 criteria [Journal of the National Cancer Institute (JNCI), Vol. 96, No. 6, March 17, 2004, Vergote JNCI 2000]
- At least 4 weeks since major surgery, with full recovery
- At least 3 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside of the radiation port.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2
- Hematologic (minimal values): Absolute neutrophil count >/= 1,500/mm^3, Hemoglobin >/= 8.0 g/dL (transfusions allowed), Platelet count >/= 100,000/mm^3
- Hepatic: Total Bilirubin </= upper limit of normal (ULN), alanine transaminase (AST) and alanine transaminase (ALT) and alkaline phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used.
- Women of childbearing potential must have a negative pregnancy test.
- Patients of childbearing potential must be willing to consent to using effective contraception while on treatment and for 3 months following the completion of treatment.
Exclusion Criteria:
Prior treatment with Docetaxel or Avastin
- Concurrent immunotherapy or hormonal therapy for the specific purpose of treatment for the ovarian cancer. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to enrollment in order for the patient to be eligible to participate in this trial. Continuation of hormonal replacement therapy is allowed.
- Peripheral neuropathy >/= grade 2
- History of a severe hypersensitivity reaction to Docetaxel, Avastin, or to other drugs formulated with polysorbate (Tween) 80.
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study of Avastin
- Blood pressure of >150/100 mmHg Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months prior to Day 1
- History of stroke within 6 months prior to Day 1
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
- Pregnant (positive pregnancy test) or lactating
- Urine protein: creatinine ratio >/= 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Evidence of malignancy in the last 5 years, other than nonmelanoma cutaneous carcinomas
- History of hemoptysis (bright red blood of 1/2 teaspoon or more) within last 3 months
- Patients believed to possibly be at higher than average risk of perforation will be excluded from study. This includes symptoms or findings of partial or complete bowel obstruction, history of fistula, patients requiring parenteral nutrition and hydration, and those with history of prior perforation due to tumor or perforation within last 6 months from other causes.
- Inability to comply with study and/or follow-up procedures.
- Patients who are not on a stable dose of anticoagulation therapy. Patients who are on a stable anticoagulation regimen, including coumadin or low molecular-weight heparin, will not be excluded.
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 |
---|---|
Experimental: Avastin and Docetaxel
Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions.
Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle.
Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle.
Response assessment every 3 cycles (9 weeks).
|
Day 1, every 21 day cycle
Otros nombres:
Day 1, 8, every 21 day cycle
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Six Month Progression Free Survival (PFS)
Periodo de tiempo: 6 months per participant
|
Percentage of participants with PFS at six months. PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions. |
6 months per participant
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Median Progression Free Survival
Periodo de tiempo: Up to 5 years
|
PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions. |
Up to 5 years
|
Overall Response Rate (RR)
Periodo de tiempo: Up to 5 years
|
Overall Response: Complete Response (CR) + Partial Response (PR).
To determine the response rate (RR) of the investigational treatment regimen.
Response and progression were evaluated in the study by using the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) method or modified Rustin Criteria for CA-125 measurements.
|
Up to 5 years
|
Occurrence of Grade 3 or 4 Toxicity
Periodo de tiempo: Up to 4 years
|
Number of participants with Grade 3 or 4 Toxicity based on 278 treatment cycles.
Toxicity was graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
Up to 4 years
|
Overall Survival (OS)
Periodo de tiempo: Up to 5 years
|
Overall Survival (OS): defined as observed length of life from entry onto the protocol to death, or for living patients, date of last contact (regardless of whether or not this contact is on a subsequent protocol).
Survival (PFS and OS) were analyzed using the Kaplan-Meier method with standard errors based on Greenwood's formula.
|
Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert M. Wenham, MD, H. Lee Moffitt Cancer Center and Research Institute
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 del Sistema Digestivo
- Neoplasias
- Neoplasias urogenitales
- Neoplasias por sitio
- Enfermedades Peritoneales
- Neoplasias Genitales Femeninas
- Enfermedades anexiales
- Neoplasias del Sistema Digestivo
- Enfermedades de las trompas de Falopio
- Neoplasias Abdominales
- Neoplasias de las trompas de Falopio
- Neoplasias Peritoneales
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Docetaxel
- Bevacizumab
Otros números de identificación del estudio
- MCC-14920
- AVF3823s (Otro identificador: Genentech)
- IST13070 (Otro identificador: Sanofi-Aventis US Inc.)
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
Ensayos clínicos sobre Avastin
-
Instituto Universitario de Oftalmobiología Aplicada...TerminadoEdema macular | Oclusión de la vena retinalEspaña
-
Shanghai Henlius BiotechTerminadoSujetos masculinos sanosPorcelana
-
Northwell HealthFeinstein Institute for Medical Research; Hofstra North ShoreSuspendidoSchwannoma vestibularEstados Unidos
-
Ronald HoffmanNational Cancer Institute (NCI); Myeloproliferative Disorders-Research ConsortiumTerminado
-
Children's Hospital Los AngelesTemporalmente no disponible
-
Instituto Universitario de Oftalmobiología Aplicada...TerminadoNeovascularización subfoveal/yuxtafoveal coroidea en miopía altaEspaña
-
Hoffmann-La RocheTerminadoGlioblastoma multiformeSuiza, Francia, Reino Unido, Dinamarca
-
University of Southern CaliforniaTerminadoRetinopatía diabética | Desprendimiento de retinaEstados Unidos
-
Universidad Autonoma de San Luis PotosíDesconocidoRetinopatía del prematuroMéxico