NCT00274859Unknown2 期
Multicenter Phase II Study Evaluating Gemcitabine and Oxaliplatin in the Treatment of Patients Suffering From Metastatic Breast Cancer Who Are Not Candidates For Treatment With Antracyclines and Taxanes
GERCOR - Multidisciplinary Oncology Cooperative Group28 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2005年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 试验地点
- 28
- 主要终点
- Objective response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in patients with metastatic cancer not amenable to anthracycline or taxane therapy treated with gemcitabine hydrochloride and oxaliplatin.
Secondary
- Determine the clinical benefit and tolerability of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed cancer
- •Metastatic disease
- •Measurable metastatic disease ≥ 1 cm by spiral CT scan and/or cutaneous lesion ≥ 2 cm
- •Not a candidate for anthracycline or taxane chemotherapy
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- •Life expectancy > 12 weeks
- •Neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3
- •Alkaline phosphatase < 5 times upper limit of normal (ULN)
- •Bilirubin < 1.5 times ULN
- •Creatinine < 1.5 times ULN OR creatinine clearance > 30 mL/min
- •SGOT and SGPT < 3 times ULN (5 times ULN if liver metastases present)
- •No pre-existing neuropathy
- •Not pregnant or nursing
- •No uncontrolled hypercalcemia
- •No familial, social, geographical, or psychological condition that would preclude study treatment
- •No other malignancy that is not considered cured
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy for metastatic disease, including anthracyclines or taxanes
- •Prior hormonal therapy allowed
排除标准
- 未提供
结局指标
主要结局
Objective response rate
次要结局
- Clinical benefit
- Tolerability
- Progression-free
- Overall survival
研究者
研究点 (28)
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