Phase II Study of High Dose Cyclophosphamide, Mitoxantrone, and Carboplatin With Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, carboplatin, and mitoxantrone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with autologous bone marrow transplant may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy and autologous bone marrow transplant work in treating patients with refractory or recurrent ovarian cancer.
详细描述
OBJECTIVES:
- Determine the response rate, duration of response, and overall survival of patients with refractory or relapsed ovarian epithelial cancer treated with high-dose cyclophosphamide, carboplatin, and mitoxantrone followed by autologous bone marrow transplantation.
- Determine the nonhematopoietic toxicity of this regimen in these patients.
OUTLINE: Autologous bone marrow is harvested before study entry. Patients receive high-dose cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4 and carboplatin IV continuously on days -8 to -3 in the absence of unacceptable toxicity. Bone marrow is reinfused on day 0 beginning at least 60 hours after completion of carboplatin infusion.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1.5-3 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 64 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of refractory or relapsed ovarian epithelial cancer
- •Must have failed prior regimen containing cisplatin or carboplatin
- •Bidimensionally measurable or evaluable disease
- •Serial CA-125 antigen titers or cytologically positive pleural effusion and/or ascites acceptable as evaluable disease
- •Autologous bone marrow harvest of greater than 1.2 x 10 to the eighth nucleated cells/kg required before study entry
- •No evidence of tumor at marrow harvest sites by bilateral bone marrow aspirates and biopsies, pelvic x-ray, and bone scan
- •CNS involvement allowed
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 8 weeks
- •Hematopoietic:
- •WBC greater than 3,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 10.0 g/dL
- •Bilirubin less than 2.0 mg/dL
- •SGOT and SGPT less than 2 times upper limit of normal
- •Creatinine clearance greater than 60 mL/min
- •No prior hemorrhagic cystitis
- •Cardiovascular:
- •LVEF greater than 45% by MUGA scan
- •No hearing loss in voice tones
- •No active infection
- •No psychological contraindication to study treatment
- •Not pregnant
- •Negative pregnancy test
- •HIV negative
- •General medical condition must allow general anesthesia
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •No prior bone marrow transplantation
- •More than 4 weeks since other prior biologic therapy and recovered
- •Chemotherapy:
- •See Disease Characteristics
- •More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •More than 4 weeks since prior radiotherapy and recovered
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Response rate
Response duration
Overall survival
Nonhematopoietic toxicity
次要结局
未报告次要终点