EUCTR2007-000035-25-DE进行中（未招募）不适用
A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (YONDELIS®) in Patients with Localized Myxoid / Round Cell Liposarcoma
Pharma Mar, S.A.0 个研究点目标入组 22 人开始时间: 2008年7月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
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
- •Patient´s written informed consent before any study-specific procedure
- •Adult patients (= 18 years)
- •Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of
- •pathology specimens for central review and pharmacogenomic studies
- •Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including
- •locally recurring disease after initial surgery
- •Measurable disease (by RECIST)
- •No prior chemotherapy or radiation (except for adjuvant post-operative
- •radiotherapy)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
- •(appendix 1)
- •Hematologic variables:
- •o Hemoglobin = 9 g/dL
- •o Absolute neutrophil count (ANC) = 1,500/µL, and
- •o Platelet count = 100,000/µL
- •Serum creatinine < 1.5 mg/dL or creatinine clearance > 30 mL/min
- •Creatinine phosphokinase (CPK) < 2.5 ULN
- •Hepatic function variables:
- •o Total bilirubin < ULN
- •o Total alkaline phosphatase < 2.5 ULN, or if > 2.5 ULN consider alkaline
- •phosphatase liver fraction or GGT or 5’ nucleotidase must be < ULN
- •o AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine
- •transaminase [SGPT]) must be <2.5 x ULN
- •Albumin > 25 g/L
- •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
- •Known hypersensitivity to any of the components of the trabectedin i.v.
- •formulation or dexamethasone
- •Pregnant or lactating women or men and women of reproductive potential who are not using effective contraceptive methods (one or more of the following):
- •- Complete abstinence from intercourse from 2 weeks prior to administration of the
- •study drug, throughout the study, and for at least 6 months after completion or
- •premature discontinuation from the study to account for elimination of the
- •investigational drug; or,
- •- Patient or patient’s partner physical sterilization; or,
- •- One of the following, for female patients or female partner of male patients:
- •o Implants of levonorgestrel; or,
- •o Injectable progestogen; or,
- •o Oral contraceptive (combined or progestogen only; subject taking oral
- •contraceptives should have been on a stable regimen for at least 2 months
- •prior to screening),or,
- •o Any intrauterine device (IUD) with published data showing that the lowest
- •expected failure rate is less than 1% per year (not all IUDs meet this
- •criterion); or,
- •o Double barrier method (2 physical barriers or 1 physical barrier plus
- •spermicide); or,
- •o Any other method with published data showing that the lowest expected
- •failure rate for that method is less than 1% per year.
- •History of another neoplastic disease (except basal cell carcinoma or cervical
- •carcinoma in situ adequately treated) unless in remission for 5 years or longer
- •Known distant metastases
- •Other serious illnesses such as congestive heart failure or angina pectoris,
- •myocardial infarction within 1 year before enrollment, uncontrolled arterial
- •hypertension or arrhythmias
- •Psychiatric disorder that prevents compliance with protocol
- •Active viral hepatitis or chronic liver disease
- •Active infection
- •Any other unstable medical condition
研究者
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