A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
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 more than one drug may kill more tumor cells. Drugs such as mesna may be effective in preventing some of the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of etoposide and ifosfamide given with mesna, and cisplatin in treating patients who have metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
- Determine the tolerability and toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to number of prior chemotherapy courses for metastatic disease (0 vs 1).
Patients receive etoposide IV over 60-90 minutes, cisplatin IV over 30 minutes, and ifosfamide IV over 30 minutes on days 1-3. Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven progressive metastatic breast cancer
- •Measurable disease
- •Any lesion measurable in 2 dimensions
- •Hepatic metastases if the sum of the measurements below the costal margin in the midclavicular line and the tip to the xiphoid process is greater than 5 cm during quiet respiration
- •Hepatic defects that are clearly measurable by radionuclide, CAT, or MRI scans
- •Bone metastases are not considered measurable disease
- •Evaluable disease allowed if measurable disease also present
- •No brain metastases, carcinomatous meningitis, or spinal cord compression
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Hemoglobin at least 10 g/dL
- •WBC at least 4,000/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than 2.0 mg/dL
- •Creatinine no greater than 1.5 mg/dL
- •No bladder outlet obstruction
- •Cardiovascular:
- •No symptomatic cardiovascular disease (e.g., congestive heart disease) or inability to tolerate a fluid load
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infection
- •No prior malignancies except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No greater than 1 prior biologic response modifier treatment for metastatic disease
- •Chemotherapy:
- •No greater than 1 prior chemotherapy regimen for metastatic disease allowed
- •Patients who relapsed during or within 6 months after adjuvant chemotherapy are considered to have failed 1 regimen
- •Patients who relapsed more than 6 months after adjuvant chemotherapy are considered to not have had a prior regimen
- •Greater than 4 weeks since prior chemotherapy (greater than 6 weeks for mitomycin or nitrosoureas) and recovered
- •No prior cisplatin, etoposide, or ifosfamide
- •Endocrine therapy:
- •Prior medical or surgical hormonal therapy allowed
- •Radiotherapy:
- •Prior radiation therapy to areas of measurable disease allowed if indicator lesion increased in size by greater than 25% after treatment
- •Recovered from effects of prior radiotherapy
- •Recovered from effects of major surgery
- •At least 7 days since prior nephrotoxic drugs (e.g., aminoglycosides, diuretics, lithium, intravenous contrast, or nonsteroidal antiinflammatory drugs)
排除标准
- 未提供
结局指标
主要结局
Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
时间窗: Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
次要结局
未报告次要终点