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A Dose-Escalating Phase I Study With an Expanded Cohort to Assess the Feasibility of Intraperitoneal Carboplatin (NSC #214240) and Intravenous Paclitaxel (NSC # 673089) and Intravenous Paclitaxel, Intraperitoneal Carboplatin and NCI Supplied Intravenous Bevacizumab (NSC #704865) in Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

adjuvant therapy

+ paclitaxel

+ carboplatin

ProcedimientoMedicamentoBiológico
Quiénes están siendo reclutados

Carcinoma+22

+ Tumor de Brenner

+ Enfermedades Urogenitales

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional
Inicio del estudio: junio de 2004
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Cancer Institute (NCI)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de junio de 2004

Fecha en la que se inscribió al primer participante.

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel during course 1, in patients with stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer who had initial debulking surgery. II. Determine the feasibility of this regimen in these patients. III. Determine the feasibility of adding IV bevacizumab to this regimen in courses 2-6. SECONDARY OBJECTIVES: I. Determine the toxicity profile of this regimen in these patients. II. Determine the toxicity profile of paclitaxel and bevacizumab IV in combination with intraperitoneal carboplatin in these patients. III. Determine the response rate (in patients with measurable disease who are in the expanded cohort) and progression-free survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal carboplatin. Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-40 patients are treated at that dose level. Patients are followed every 3 months for 1 year.

Título OficialA Dose-Escalating Phase I Study With an Expanded Cohort to Assess the Feasibility of Intraperitoneal Carboplatin (NSC #214240) and Intravenous Paclitaxel (NSC # 673089) and Intravenous Paclitaxel, Intraperitoneal Carboplatin and NCI Supplied Intravenous Bevacizumab (NSC #704865) in Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma 
NCT00079430
Patrocinador PrincipalNational Cancer Institute (NCI)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 113 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Mujer

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

CarcinomaTumor de BrennerEnfermedades UrogenitalesAdenocarcinomaEnfermedades AnexialesEnfermedades del Sistema EndocrinoNeoplasias de Glándulas EndocrinasCarcinoma de ovario epitelialEnfermedades GenitalesNeoplasias de las trompas de FalopioEnfermedades de las trompas de FalopioEnfermedades Genitales FemeninasTrastornos GonadalesCistadenocarcinomaEnfermedades Urogenitales Femeninas y Complicaciones del EmbarazoNeoplasias Genitales FemeninasNeoplasiasNeoplasias por SitioNeoplasias por tipo histológicoNeoplasias glandulares y epitelialesNeoplasias del tejido conjuntivoEnfermedades del OvarioNeoplasias OváricoNeoplasias UrogenitalesNeoplasias uterinas

Criterios

Inclusion Criteria: * Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer * Stage II-IV disease * The following histologic epithelial cell types are eligible: * Serous adenocarcinoma * Mucinous adenocarcinoma * Clear cell adenocarcinoma * Transitional cell carcinoma * Adenocarcinoma not otherwise specified * Endometrioid adenocarcinoma * Undifferentiated carcinoma * Mixed epithelial carcinoma * Malignant Brenner's tumor * Optimal (≤ 1 cm residual disease) OR suboptimal residual disease after initial debulking surgery (performed within the past 12 weeks) * Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true: * Stage IB disease or less * Less than 3 mm invasion without vascular or lymphatic invasion * No poorly differentiated subtypes, including the following: * Papillary serous * Clear cell * Other FIGO grade 3 lesions * No epithelial tumors of low malignant potential (borderline tumors) * No CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases by history or evidence upon physical examination within the past 6 months * Performance status - GOG 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * INR ≤ 1.5 * PTT \< 1.2 times upper limit of normal (ULN) * No active bleeding or pathologic conditions carrying high risk of bleeding (e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels) * AST ≤ 3 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3 times ULN * Bilirubin ≤ 1.5 times ULN * No acute hepatitis * Creatinine ≤ 2.0 mg/dL * Urine protein-creatinine ratio \< 1.0 OR protein 1.0 g by 24 hour urine collection * Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided the patient's cardiac status has been stable for ≥ 6 months before study entry * No clinically significant cardiovascular disease, including any of the following: * Uncontrolled hypertension, defined as systolic BP \> 150 mm Hg or diastolic BP \> 90 mm Hg * Myocardial infarction or unstable angina within the past 6 months * New York Heart Association class II-IV congestive heart failure * Serious cardiac arrhythmia requiring medication * Peripheral vascular disease ≥ CTCAE grade 2 (at least brief (\< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit) * No history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within the past 6 months * Not pregnant or nursing * Fertile patients must use effective contraception during and for ≥ 6 months after completion of bevacizumab therapy * No neuropathy (sensory and motor) \> grade 1 * No active infection requiring antibiotics * No circumstances that would preclude study participation * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * No history of allergic reaction to polysorbate 80 (e.g., etoposide, vitamin E) * No other invasive malignancies within the past 5 years except non-melanoma skin cancer or localized breast cancer * No serious, non-healing wound, ulcer, or bone fracture * No significant traumatic injury within 28 days prior to bevacizumab therapy * No prior history of abdominal fistula or gastrointestinal perforation within the past 3-6 months * Granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection allowed but require weekly wound examinations * No clinical symptoms or signs of gastrointestinal obstruction requiring parenteral hydration and/or nutrition * At least 28 days since intra-abdominal abscess and recovered * At least 3 years since prior adjuvant chemotherapy for localized breast cancer * Patients must remain free of recurrent or metastatic disease * At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin * Patient must remain free of recurrent or metastatic disease * No prior radiotherapy to any portion of the abdominal cavity or pelvis * No concurrent amifostine or other protective agents * No concurrent major surgical procedure or open biopsy or within 28 days prior to bevacizumab therapy * No core biopsy within 7 days prior to bevacizumab therapy * No prior therapy for this malignancy * No prior cancer treatment that contraindicates study therapy * No prior anti-VEGF drug, including bevacizumab

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 19 ubicaciones

Suspendido

University of California Medical Center At Irvine-Orange Campus

Orange, United StatesVer ubicación
Suspendido

University of Chicago

Chicago, United States
Suspendido

University of Iowa Hospitals and Clinics

Iowa City, United States
Suspendido

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, United States
Completado19 Centros de Estudio