EUCTR2006-003816-23-DE进行中（未招募）不适用
Multicenter phase II study with pemetrexed in patients with pre-treated metastatic soft tissue sarcomas
niversitätsklinikum Tübingen0 个研究点开始时间: 2006年10月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Histologically confirmed metastasized or locally inoperable soft tissue sarcoma
- •- Progression or relapse after previous cytostatic treatment with adriamycin and/or an ifosfamide containing chemotherapeutic substance
- •- Two-dimensionally measurable/evaluable tumor parameters
- •- Previous radiotherapy is acceptable as long as the irradiated area does not include the only measurable lesion
- •- Patient compliance and geographic proximity, which ensure the possibility of adequate Follow-up
- •- Life expectancy of more than 3 months
- •- ECOG <= 2
- •- Age at least 18 years
- •- Adequate bone marrow function at the initiation of therapy
- •- Adequate kidney function
- •- Patient consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Previous or concurrent irradiation of the indicator lesion
- •- Other concomitant tumor therapy
- •- Severe impairment in hepatic function
- •- Active Infection
- •- Previous treatment with Pemetrexed
- •- Second tumor within the past 5 years
- •- Severely symptomatic cardiovascular and cerebrovascular disease
- •- HIV, active Hepatitis B or C
- •- Dementia, Cerebral stroke with cognitive deficits
- •- Kidney function <= 79 ml/min (calculated according to MDRD) and inability to interrupt treatment with NSAIDs 2 days prior to and following administration of Pemetrexed
- •- Inability or unwillingness to take folic acid, vitamin B12 or dexamethasone
- •- Pleural or pericardial exudate, ascites without a drain (3rd Space)
- •- Time Interval from the last course of chemotherapy < 4 weeks
- •- Symptomatic CNS-Metastases
- •- Gravidity or Lactation
- •- Women of reproductive age without reliable contraception (neg. pregnancy test)
- •- Participation in another clinical trial at the same time
研究者
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