NCT00427466已完成2 期
Multicenter Phase II Study With Pemetrexed in Patients With Pre-Treated Metastatic Soft Tissue Sarcomas
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Rate of response
研究概览
简要总结
The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-based chemotherapy and to assess the toxicity profile
详细描述
One therapy cycle takes a total of 3 weeks. On day 1, Pemetrexed is intravenously administered. The dosage is 500 mg/m2 over a period of 10 minutes. A repetition of this procedure is performed on day 22
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 (according to WHO-criteria)
- •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
- •Patient ability to consent
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 (excepting basal cell carcinoma, adequately treated carcinoma in situ of the uterine cervix, of the bladder urothelium or colon polyps including pTis and pTin)
- •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): Inability to interrupt treatment with NSAIDs/ASS/Cox-2 Inhibitors 2 days prior to and following administration of Pemetrexed. If a patient is taking an NSAID or salicylate with a long half-life it should not be taken five days prior to, on the day of or two days after application of Pemetrexed. Low dose acetyl salicylic acid administration is permitted (e.g. 100 mg/die.) There are no restrictions with kidney function greater than 80 ml/min.
- •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 if not the following applies: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after treatment
- •Positive serum or urine pregnancy test
- •Participation in another trial at the same time
结局指标
主要结局
Rate of response
次要结局
- Rate of patients who are progression free at 3 and 6 months
- Changes in median period of survival
- Progression free survival
- Toxicity
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Pemetrexed in Patients With Advanced Neuroendocrine TumorsNeuroendocrine TumorsNCT00424723Dana-Farber Cancer Institute32
已完成
2 期
A Trial for Patients With Advanced/Recurrent Endometrial CancerNeoplasms by SiteUrogenital NeoplasmsGenital Neoplasms, FemaleUterine NeoplasmsEndometrial NeoplasmsCancer of EndometriumEndometrial CancerCancer of the EndometriumEndometrium CancerNeoplasms, EndometrialNeoplasmsNCT00377520Eli Lilly and Company27
Unknown
2 期
Pemetrexed + Paclitaxel in Patients With Recurrent/Advanced Thyroid CancerThyroid CancerNCT00786552University Hospital Schleswig-Holstein47
撤回
2 期
Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System LymphomaPrimary Central Nervous System LymphomaNCT00712062University of Florida
进行中（未招募）
不适用
Multicenter phase II study with pemetrexed in patients with pre-treated metastatic soft tissue sarcomaspatients with previously treated metastatic soft tissue sarcomaEUCTR2006-003816-23-DEniversitätsklinikum Tübingen