A Phase I Study of Extended Field Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients Cervical Carcinoma Metastatic to the Para-Aortic Lymph Nodes
cisplatin
+ paclitaxel
+ brachytherapy
Enfermedades Urogenitales+9
+ Enfermedades Genitales
+ Enfermedades del cuello uterino
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the toxicity of extended field radiotherapy with concurrent paclitaxel and cisplatin chemotherapy (as radiation sensitization) in patients with previously untreated carcinoma of the cervix metastatic to the para-aortic lymph nodes. Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus extended field radiotherapy in this patient population. Determine the effect of this treatment regimen on progression-free survival, overall survival, and site of recurrence (local vs distant) in these patients. OUTLINE: This is a multicenter, dose-escalation study of paclitaxel. Patients receive external beam radiotherapy (RT) to the para-aortic nodes and the pelvis daily for 5 weeks; RT must be completed within 8 weeks of its initiation. During or after external beam RT, intracavitary radiation is administered 1-5 times. Concurrently with external beam RT, patients receive paclitaxel IV over 1 hour followed immediately by cisplatin IV on days 1, 8, 15, 22, 29, and 36. Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or until the time of recurrence or death. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 4 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 29 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.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
Criterios
DISEASE CHARACTERISTICS: Histologically proven previously untreated invasive carcinoma of the uterine cervix Squamous cell carcinoma Adenosquamous carcinoma Adenocarcinoma TNM classification stage IIIB or IVA (FIGO classification stage IB, IIA, IIB, IIIA, IIIB, or IVA) Cytologically or histologically proven metastases to the para-aortic lymph nodes No more than 8 weeks since diagnosis No metastases to scalene nodes, intraperitoneal metastases, or metastases to other organs outside the radiation field at the time of original clinical and surgical staging Negative CT scan of the chest Patients with ureteral obstruction must be treated with stent or nephrostomy tube PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Renal: Creatinine less than 2.0 mg/dL No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) requiring modification of radiation fields Other: Not pregnant No septicemia or severe infection No other invasive malignancy within the past 3 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy for this or other malignancy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for this or other malignancy No prior radiotherapy to pelvis or abdomen Surgery: Not specified Other: No other prior therapy for this malignancy
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
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 13 ubicaciones
University of Miami Sylvester Comprehensive Cancer Center
Miami, United StatesAbrir University of Miami Sylvester Comprehensive Cancer Center en Google MapsUniversity of Chicago Cancer Research Center
Chicago, United StatesHolden Comprehensive Cancer Center at University of Iowa
Iowa City, United StatesCancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Camden, United States