NCT00004115Unknown3 期
Multicenter Randomized Survival Study of Monoclonal Antibody Radioimmunotherapy: A Multinational Study in Patients With Ovarian Carcinoma Using the HMFG1 Antibody Labeled With 90Yttrium
适应症
试验速览
- 阶段
- 3 期
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is more effective than observation for ovarian cancer or primary peritoneal cancer that is in remission.
PURPOSE: Randomized phase III trial to compare the effectiveness of monoclonal antibody therapy with that of observation in treating patients who have ovarian cancer or primary peritoneal cancer in remission following surgery and chemotherapy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status:
- •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
- •SGOT/SGPT no greater than 2 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL
- •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
- •See Disease Characteristics
- •No concurrent participation in other trials involving adjuvant cancer treatment
- •No other concurrent experimental therapies
排除标准
- 未提供
研究者
研究点 (1)
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