Multicenter Phase II/III Clinical Study of Lipoplatin plus Gemcitabine as First-Line Treatment in Inoperable, Locally Advanced or Metastatic Pancreatic Cancer.

Regulon ?.?.0 个研究点目标入组 328 人开始时间: 2009年10月21日最近更新: 2016年11月28日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 328

研究概览入排标准研究者记录与标识符相似试验

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

•Adult male or female 18-70 years old.
•Histologically or cytologically confirmed diagnosis of locally advanced or metastatic inoperable adenocarcinoma of the pancreas
•Presence of at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors. (RECIST, see Appendix II).
•WHO performance status (PS) 0-1 (Appendix I).
•Life expectancy of at least 3 months.
•At least 4 weeks since prior major surgery, with full recovery from all side effects.
•Adequate bone marrow function (defined as peripheral absolute granulocyte count > 2000/mm3 and platelet count = 140000/mm3).
•Adequate liver function (bilirubin = 2 mg/dl, SGOT or SGPT no greater than 2.5 x ULN or 4 x ULN in case of hepatic metastasis).
•Adequate renal function (creatinine = 1.5 mg/dl, creatinine clearance = 60ml/min). Clearance to be measured after 24-hour urine collection, or calculated by the following formulas:
•CrClmale=[(140-age)*(wt. as kg)]/[(serum Cr mg/dl)x72]
•CrClfemale=0.85*(CrClmale)
•Patients must understand and sign an informed consent document that explains the neoplastic nature of his/her disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, and potential risks and toxicities.
•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

•Other malignancy within the past 5 years, except malignancies with <5% probability of recurrence, curatively treated squamous or basal cell skin carcinoma, or in situ carcinoma of the cervix.
•Known allergy to any of the study drug components.
•Prior chemotherapy, radiotherapy or investigational drug treatment for pancreatic cancer.
•Known brain metastases.
•Malnutrition (>25% weight loss).
•Recent history of myocardial infarction (within the last 6 months), history of congestive heart failure, congenital heart disease, or ventricular arrhythmias.
•Known Hepatitis B or C, or AIDS.
•Known underlying immune deficiency or history of autoimmune diseases (e.g. autoimmune neutropenia, hemolytic anaemia or thrombocytopenia, systemic lupus erythematosus, Sjögren syndrome, Addison’s disease, scleroderma, myasthenia Gravis, Goodpasture’s syndrome, Hashimoto’s thyroiditis or other diseases of autoimmune origin).
•Pregnant or lactating women. For women of childbearing age an initial negative pregnancy test and usage of a reliable contraceptive method during and for 3 months after study participation is a requirement.
•Any medical, psychiatric or social condition that would preclude informed consent (e.g. homeless patients or with dementia).
•Patients for whom compliance with the protocol is doubtful.

研究者

发起方

Regulon ?.?.

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