HIGH-DOSE CHEMOTHERAPY WITH CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CARBOPLATIN FOLLOWED BY RESCUE WITH AUTOLOGOUS BONE MARROW AND AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH POOR PROGNOSIS BREAST CANCER
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with combinations of drugs may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of high-dose combination chemotherapy followed by peripheral stem cell transplantation or autologous bone marrow transplantation in women with stage II breast cancer with eight or more positive axillary lymph nodes and in women with stage III or metastatic breast cancer.
详细描述
OBJECTIVES: I. Investigate the curative potential of high-dose cyclophosphamide, etoposide, and carboplatin followed by autologous stem cell rescue in women with breast cancer considered incurable by conventional therapy. II. Observe the overall response rate, survival rate, and toxicity associated with this regimen.
OUTLINE: Prior to therapy, patients undergo collection of peripheral blood stem cells (PBSC) on another protocol; patients with marrow involvement undergo PBSC harvest only, while all others may also undergo bone marrow harvest. All patients receive cyclophosphamide, etoposide, and carboplatin over 4 consecutive days, followed 3 days later by PBSC or bone marrow and granulocyte colony-stimulating factor. Patients are followed for duration of remission and survival.
PROJECTED ACCRUAL: 100-200 patients will be entered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供