Suspendido

A Phase II Evaluation of Weekly Paclitaxel (NSC #673089) and Celecoxib (Celebrex®, NSC #719627) in the Treatment of Recurrent or Persistent Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Cancer

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

Colección de datos

Quiénes están siendo reclutados

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

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: abril de 2004
Ver detalles del protocolo

Resumen

Patrocinador PrincipalGynecologic Oncology Group
Última actualización: 13 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de abril de 2004

Fecha en la que se inscribió al primer participante.

OBJECTIVES: * Determine the antitumor activity of paclitaxel and celecoxib in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer. * Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and oral celecoxib twice daily on days 2-6, 9-13, and 16-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.

Título OficialA Phase II Evaluation of Weekly Paclitaxel (NSC #673089) and Celecoxib (Celebrex®, NSC #719627) in the Treatment of Recurrent or Persistent Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Cancer 
NCT00084448
Patrocinador PrincipalGynecologic Oncology Group
Última actualización: 13 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.

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.
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.

Criterios

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal cancer * Recurrent or persistent disease * Measurable disease * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * At least 1 target lesion not in a previously irradiated field * Must have received 1 prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or another organoplatinum compound * Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment * Platinum-resistant or refractory (i.e., had a treatment-free interval after platinum therapy of less than 6 months OR disease progression during platinum-based therapy) * Patients who have not received a prior taxane may have received a second regimen that included paclitaxel or docetaxel * Must not be eligible for a higher priority GOG protocol PATIENT CHARACTERISTICS: Age * Not specified Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * SGOT ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics * No neuropathy (sensory and motor) \> grade 1 * No history of peptic ulcer disease * No allergies to sulfa or non-steroidal anti-inflammatory drugs * No known hypersensitivity to paclitaxel or celecoxib * No other invasive malignancy within the past 5 years except non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 weeks since prior biologic or immunologic therapy * One prior non-cytotoxic\* regimen for recurrent or persistent disease allowed NOTE: \*Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy * No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimen Endocrine therapy * At least 1 week since prior hormonal therapy for malignant tumor * Concurrent hormone replacement therapy allowed Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy * No prior radiotherapy to more than 25% of marrow-bearing areas Surgery * See Disease Characteristics * Recovered from prior surgery Other * At least 3 weeks since prior therapy for malignant tumor * No prior celecoxib * No prior therapy for a previous cancer that would preclude protocol therapy * No concurrent amifostine or other protective agents

Plan de Estudio

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

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

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Este estudio tiene una ubicación

Suspendido

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, United StatesVer ubicación
Suspendido1 Centros de Estudio