EUCTR2007-005398-73-SE进行中（未招募）不适用
Treatment of malignant mesothelioma with pemetrexed (Alimta) + platinum (4 courses) or pemetrexed (Alimta) + platinum (4 courses) followed by Caelyx single drug (4 courses). - The Pea-Fowl Study
Karolinska University Hospital0 个研究点目标入组 125 人开始时间: 2008年2月22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
- 入组人数
- 125
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
- •Patients may be included in the study only if they meet ALL of the following criteria:
- •1.Histologically (or cytologically if later confirmed by a mesothelioma panel) proven diagnosis of mesothelioma of the pleura, with subtyping (epitheloid, mixed, sarcomatous or not classifiable). Not a candidate for potentially curative surgery (see Appendix). All stages.
- •2.At least one unidimensionally measurable lesion(s) of the pleura with clearly defined margins by computerized tomography (CT) with a thickness of ³1 cm OR for example measurable lymph node(s) (or both). The CT scan should not be older than 28 days before start of treatment.
- •3.Patients may have undergone pleurodesis. If so, a minimum delay of 28 days must follow before study drugs are administered. If the original CT scan was performed prior to the pleurodesis, a new CT scan is required 28 or more days after the pleurodesis, which will then be considered the baseline scan.
- •4.Prior radiation therapy allowed to <25 % of the bone marrow. Prior radiotherapy must be completed at least 14 days before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
- •5.WHO Performance status of 2 or lower (after any palliative measures including pleural drainage). Estimated life expectancy at least 8 weeks.
- •6.Patient compliance and geographic proximity allowing adequate follow-up.
- •7.Adequate organ function including the following:
- •Bone marrow: Leukocytes (WBC) ³3.0 ? 109/l. Platelets ?100 ? 109/l. Hemoglobin ?10 g/dl.
- •Hepatic: Bilirubin ? 1.5 times the upper limit of normal (ULN). Alkaline phosphatase, aspartate transaminase (AST) or alanine transaminase (ALT) ???? x ULN (alkaline phosphatase, AST, ALT ?5 x ULN is acceptable if tumour involvement of the liver).
- •Renal: Calculated creatinine clearance (CrCl) ?45 ml/min
- •8.Signed informed consent from patient.
- •9.> 18 years of age.
- •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
- •Patients will not be enrolled if ANY of the following criteria apply:
- •1.Previous treatment with cytostatic chemotherapy within 5 years. Patients on low-dose methotrexate for rheumatoid arthritis or other diseases cannot be included.
- •2.Any other active malignant disease within 5 years, except basal or squamous cell carcinoma of the skin or cancer of the cervix Stage I.
- •3.Cardiomyopathy. Cardiac disease with a cardiac dysfunction NYHA class III or IV (Appendix).
- •4.History of severe hypersensitivity reactions to any of the trial drugs.
- •5.Clinically significant hepatic disease.
- •6.Uncontrolled bacterial, viral, or fungal infection.
- •7.Other serious concomitant systemic disorders that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator.
- •8.Patient is pregnant or breast-feeding. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment. Patient of childbearing potential should use contraceptive.
- •9.Confusion, disorientation, or any other condition (medical, social, and psychological) which could prevent adequate information and follow-up.
- •10.Inability to interrupt salicylates or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam).
- •11.Inability or unwillingness to take folic acid or vitamin B12 supplementation.
- •12.Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.
研究者
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