Multicenter Randomized Survival Study of Monoclonal Antibody Radioimmunotherapy: A Multinational Study in Patients With Ovarian Carcinoma Using the HMFG1 Antibody Labeled With 90Yttrium
yttrium Y 90 monoclonal antibody HMFG1
Enfermedades Urogenitales+15
+ Enfermedades Genitales
+ Enfermedades Anexiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the efficacy of yttrium Y 90 monoclonal antibody HMFG1, in terms of survival, in patients with ovarian epithelial carcinoma in remission after debulking surgery and platinum-based chemotherapy. Determine the toxicity and tolerability of this treatment regimen in these patients. Determine the quality of life of patients treated with this regimen. Evaluate this treatment regimen, in terms of the time to relapse, ECOG performance status, frequency of hospitalization, changes in concurrent medication, and incidence and severity of adverse events, in this patient population. OUTLINE: This is a randomized, parallel, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive standard therapy (observation). Arm II: After imaging studies of the peritoneal cavity to verify adequate fluid distribution, patients receive yttrium Y 90 monoclonal antibody HMFG1 intraperitoneally over 1 minute. Quality of life is assessed in all patients prior to randomization, at weeks 4 and 8, at 3 months, and then every 3 months thereafter. Patients in arm I are followed at weeks 1, 4, and 8. Patients in arm II are followed weekly for 6 weeks and at weeks 8 and 12. All patients are followed every 3 months for 3 years. PROJECTED ACCRUAL: A total of 420 patients (210 per treatment arm) will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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 stage IC, II, III, or IV ovarian epithelial carcinoma or primary peritoneal serous carcinoma Prior complete response to 1 platinum-based chemotherapy regimen consisting of at least 5 courses Absence of disease on physical and radiological exam (CT scan/MRI) CA 125 normal No visible evidence of malignant disease on second-look laparoscopy No disease relapse even if complete response to a second course of chemotherapy Prior bilateral oophorectomy with or without salpingectomy, omentectomy, and total or partial abdominal hysterectomy required No known metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10.0 g/dL Hepatic: SGOT/SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Other: No other malignancy except basal cell skin cancer No serious physical or psychiatric disease that would preclude study entry No significant loculation that would preclude good distribution of study medication Human antimouse antibody negative PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine antibody Chemotherapy: See Disease Characteristics No more than 4-8 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent participation in other trials involving adjuvant cancer treatment No other concurrent experimental therapies
Centros del Estudio
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