- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00008138
S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer (S0009)
Phase II Evaluation Of Neoadjuvant Chemotherapy, Interval Debulking Followed By Intraperitoneal Chemotherapy In Women With Stage III And IV Epithelial Ovarian Cancer, Fallopian Tube Cancer Or Primary Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in treating patients who have stage III or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Evaluate the overall survival and progression-free survival in patients with stage III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer treated with neoadjuvant paclitaxel and carboplatin followed by surgery and adjuvant paclitaxel and carboplatin.
- Estimate the percentage of these patients whose disease is successfully cytoreduced to less than 1 cm in diameter following neoadjuvant chemotherapy.
- Evaluate the toxicity of this regimen in these patients.
- Explore the relationship between tumor p53 expression, proliferation rate as measured by proliferating cell nuclear antigen and apoptotic rate, and human tumor cloning assay results at time of debulking surgery with progression-free survival and overall survival in these patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive neoadjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Within 35 days of receiving the third course of chemotherapy, patients with at least a 50% reduction in CA 125 undergo debulking surgery. Within 35 days of undergoing surgery, patients with a tumor reduction to below 1 cm receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 5 years.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 3 years.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
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, primary peritoneal cancer, or fallopian tube cancer
- Adenocarcinoma
- Large pelvic mass and/or bulky abdominal disease and/or malignant pleural effusion
- Pleural effusion only for stage IV (parenchymal, liver, lung, or other distant metastases not allowed)
- No borderline or low-malignant potential tumors
- Optimal cytoreduction clinically deemed unlikely
- CA 125 at least 70 units/mL
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- SGOT no greater than 2 times ULN
Renal:
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No congestive heart failure or cardiac arrhythmia
- No myocardial infarction or angina within past 6 months
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No severe gastrointestinal symptoms (i.e., partial obstruction) and/or gastrointestinal bleeding
- No grade 2 or greater sensory neuropathy
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
- No active or uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy for this cancer
Chemotherapy:
- No prior chemotherapy for this cancer
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior pelvic radiation for this cancer
Surgery:
- See Disease Characteristics
- Prior exploratory laparotomy allowed provided an aggressive tumor debulking procedure was not performed (e.g., bilateral salpingo-oophorectomy/total abdominal hysterectomy with omentectomy)
- Prior salpingo-oophorectomy and/or partial omentectomy allowed
Other:
- No other concurrent anti-cancer therapy
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: chemo/debulking surgery/IP chemo
neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
|
pre-surgery - target AUC=6, Day 1 IV, q 21 days X 3 cycles post-surgery - target AUC=5, Day 1 IP, q 28 days X 6 cycles
Otros nombres:
pre-surgery - 175 mg/m2 IV Day 1, q 21 days X 3 cycles post-surgery - 175 mg/m2 IV Day 1, q 28 days X 6 cycles AND 60 mg/m2 IP Day 8, q 28 days X 6 cycles
Otros nombres:
exploratory laparotomy, interval cytoreduction (to < 1 cm residual)
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall Survival
Periodo de tiempo: assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5
|
Overall survival was defined as the time from the date of registration until the date of death due to any cause.
Patients last known to be alive were censored at the date of last contact.
Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.
|
assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5
|
Progression-Free Survival
Periodo de tiempo: Monthly during protocol treatment, then every 3 months up to the end of Year 1, then every 6 months for the next two years, then annually up to Year 5.
|
Progression was defined as a CA-125 value that is both twice the nadir since registration and greater than 70 units/ml, and is confirmed by a second determination at least 7 days apart, or appearance of any new lesion/site.
Symptomatic deterioration was defined as a global deterioration of health status requiring removal from protocol treatment.
Progression-Free Survival was defined as the time from the date of registration to the date of progression, symptomatic deterioration, or death due to any cause.
Patients last known to be alive and progression-free were censored at last contact date.
|
Monthly during protocol treatment, then every 3 months up to the end of Year 1, then every 6 months for the next two years, then annually up to Year 5.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Amy D. Tiersten, MD, NYU Langone Health
Publicaciones y enlaces útiles
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
- cáncer epitelial de ovario en estadio III
- cáncer epitelial de ovario en estadio IV
- cáncer de trompa de Falopio
- cistoadenocarcinoma seroso de ovario
- adenocarcinoma indiferenciado de ovario
- cistoadenocarcinoma de células claras de ovario
- adenocarcinoma endometrioide de ovario
- cistoadenocarcinoma mucinoso de ovario
- cáncer de cavidad peritoneal
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
- Enfermedades de las trompas de Falopio
- Neoplasias Ováricas
- Neoplasias de las trompas de Falopio
- Carcinoma Epitelial De Ovario
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Carboplatino
- Paclitaxel
Otros números de identificación del estudio
- CDR0000068380
- U10CA032102 (Subvención/contrato del NIH de EE. UU.)
- S0009 (Otro identificador: SWOG)
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. .
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