EUCTR2006-005301-63-AT进行中（未招募）1 期
Phase II Trial of Docetaxel in Patients With Metastatic or Inoperable Medullary Thyroid Cancer
niversity Hospital Vienna0 个研究点开始时间: 2006年12月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Signed informed consent
- •Histologically confirmed medullary thyroid cancer
- •Meatastatic or inoperable locoregional disease
- •Disease assesable by CT scan
- •Age 18 - 75
- •ECOG Performance status 0-2
- •Life expectancy more than 3 months
- •Hematopoietic: Leukocyte count > 3,000/mm^3, Platelet count > 100,000/mm^3
- •Hepatic: Bilirubin < 1.5 mg/dL, ALT and AST < 2.5 times upper limit of normal, no unstable or uncompensated hepatic disease
- •Renal: normale serum kreatinine values or creatinine clearance > 60 mL/min, no unstable or uncompensated renal disease
- •Cardiovascular : no unstable or uncompensated cardiovascular disease
- •Pulmonary: no unstable or uncompensated respiratory disease
- •In women of childbearing age: negative pregnancy test and sufficient method of contraception during the whole duration of therapy
- •No other severe or uncontrolled systemic disease
- •No other illness that would preclude study participation
- •No other significant clinical disorder or laboratory finding that would preclude study participation
- •More than 4 weeks since prior biologic therapy
- •More than 4 weeks since prior chemotherapy or complete reconstitution of blood counts (i.e. Leuko > 3000, Thrombo > 100.000)
- •No prior radiotherapy to > 25% of bone marrow
- •More than 4 weeks since prior radiotherapy or complete reconstitution of blood counts (i.e. Leuko > 3000, Thrombo > 100.000)
- •Full recovery from prior oncologic or other major surgery, minimal time span of 3 weeks following surgery
- •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
- •Absence of inclusion criteria (as stated above)
- •Use of any investigational agent in the month prior to inclusion
- •History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
- •Major surgery, other than diagnostic surgery, within the last 3 weeks
- •Evidence of CNS involvement
- •A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
- •Significant polyneuropathy interfering with everyday activities
- •Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
- •Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands)) <1.0 x 109/L
- •Renal insufficiency
- •Patients with active opportunistic infections
- •Pregnancy and lactation
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