NCT00204620已完成2 期
Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
研究概览
简要总结
The aims of this trial are to evaluate the efficacy of bendamustin in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-baesd chemotherapy and to assess the treatment of toxicity.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic or non-resectable soft tissue sarcoma
- •Evidence of progression or relapse after an anthracycline-based and/ or ifosfamide-based chemotherapy
- •At least 1 bidimensionally measurable tumor lesion according to RECIST criteria
- •No previous radiation therapy on the only measurable lesion
- •Willingness to receive regular follow-up
- •Life expectancy more than 3 months
- •ECOG status >= 2
- •Patients aged 18 years and beyond
- •leucocytes > 2500/µl, thrombocytes > 75000/µl)
- •Serum creatine < 1,5 times the upper limit of normal value, GFR > 60/ml
- •Written patient informed consent
- •Ability to give informed consent
排除标准
- •Previous or concurrent radiation of the index lesion (radiation of single lesion is allowed if not the index lesion)
- •Insufficient liver function (bilirubin > 1.5 the upper limit of normal, prolongation of PT and aPTT > 1.5 the upper limit of normal; ASAT and ALAT > 3 the upper limit of normal (patients with liver metastases ASAT and ALAT > 5 the upper limit of normal)
- •Active infection
- •Prior therapy with Bendamustin hydrochloride
- •Prior malignancies (other than adequately treated carcinoma in situ (CIS) of the cervix, bladder urothelium, basal cell carcinoma or adenoma of the colon including pTIS,pTIN), unless treated with curative intent and without evidence of disease > 5 years
- •Symptomatic cardio- and/or cerebrovascular disease (NYHA-Scale III°)
- •Interval since last chemotherapy < 4 weeks
- •Evidence of CNS-metastases
- •Evidence of pregnancy or lactation
- •Woman of child-bearing potential without reliable methods of birth control
研究者
研究点 (1)
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