EUCTR2014-003596-27-ES进行中（未招募）1 期
A Phase II Study of Nab-paclitaxel and Gemcitabine, in Elderly Patients with Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Asociación de Oncología Médica del Hospital de Cruces (ASONMEC)0 个研究点目标入组 80 人开始时间: 2015年1月16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
- 入组人数
- 80
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
入选标准
- •1. Histologically or citologically-confirmed pancreatic adenocarcinoma
- •2. Stage IV disease (metastatic only)
- •3. No prior systemic therapy for their diagnosis (except in adjuvant setting > six months previously)
- •4. ECOG performance status of 0-1
- •5. Age >=70 years.
- •6. Evidence of either or both of the following:
- •- RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter >= 20mm using conventional techniques or >= 10 mm with spiral CT scan)
- •- An elevated serum CA19-9 at baseline ( >= 2X ULN)
- •7. Female patients must be either surgically sterile or postmenopausal.
- •8. Male patients must be surgically sterile or must agree to use a condom during sex with women who may become pregnant while receiving the study drug and for 6 months after receiving the last dose.
- •9. Adequate bone marrow function:
- •- ANC >= 1500/uL
- •- platelet count >= 100,000/uL
- •- hemoglobin >= 9.0 g/dL
- •10. Adequate hepatic function:
- •- Total bilirubin <= 1.5 X ULN
- •- AST (SGOT) <= 2.5 X ULN
- •- ALT (SGPT) <= 2.5 X ULN
- •11. Adequate renal function as determined by either:
- •- Serum creatinine <= 1.5 X ULN
- •- Calculated or measured creatinine clearance >= 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used).
- •12. Ability to understand the nature of this study protocol and give written informed consent
- •13.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 80
排除标准
- •1. Any prior systemic or investigational therapy for metastatic pancreatic cancer.
- •2. Inability to comply with study and/or follow-up procedures.
- •3. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
- •4. Presence of central nervous system or brain metastases.
- •5. Life expectancy < 12 weeks.
- •6. Pregnancy (positive pregnancy test) or lactation.
- •7. Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.
- •8. 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 12 months.
- •9. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- •10. Known, existing uncontrolled coagulopathy.
- •11. Pre-existing sensory neuropathy > grade 1.
- •12. Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- •13. Concurrent/pre-existing use of coumadin.
研究者
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