Estudio Fase II abierto de Capecitabina (Xeloda®) como fluoropirimidina de elección en combinación con quimioterapia en pacientes con cáncer gástrico Avanzado y/o Metastático susceptibles de ser tratados con un régimen basado en fluoropirimidinas

Roche Farma, S.A.0 个研究点目标入组 154 人开始时间: 2010年3月4日最近更新: 2012年4月18日

适应症

试验速览

暂无简介。

•1.Signed inform consent prior to any study specific procedure.
•2.Advanced or metastatic gastric Adenocarcinoma histológically confirmed.
•3.Age> 18.
•4.Creatinina clearance > 60 mi/min, measured at baseline based on Cockroff – Gault formula (In case that the creatinitn clearance calculated by the formula is < 60 ml/min, it should be calculated again by collecting 24 hours urine. If the value is > 60 ml/min, the patient is elegible).
•5.ECOG <2
•6.Life expectancy of at least 3 months.
•7.Be willing an able to comply with protocol requerimient.
•8.Patients with measurable and non-measurable disease could be included.
•Are the trial subjects under 18?
•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

•1.Pregnancy or lactatig woman. Woman with reproductive potential unless using an effective method of contraception (Postmenopausic woman must have been amenorreic during at least 12 months).
•2.Previous chemotherapy (except if administered as adjuvant or neoadyuvant treatment and was finalized at least 6 months prior recruitment)
•3.Organ transplant (liver and kidney)
•4.Cardiac disease clinically significant (for example, congestive heart failure, clinically significant valvular heart disease, high risk uncontrollable arrithmias) or myocardial infarction during the last 12 months.
•5.Evidence of metastasis in the central nervous system (CNS).
•6.History of any other neoplasia during the last 5 years at exception of cellular basal carcinoma of skin already cured and in-situ carcinoma of the cérvix uterus already cured.
•7.Laboratory values::
•neutrófils < 1.5 x 109 /L, platelets < 100 x 109 /L
•serum bilirrubina > 1.5 x upper normal limit.
•ALT, AST > 2.5 x upper normal limit o > 5 x upper normal limit in case of hepatic metastasis.
•Alkaline Phosphatase > 2.5 upper normal limit o 5 x upper normal limit in case of hepatic metastasis o > 10 x upper normal limit in case of bone disease)
•8.Major surgery within 4 weeks of start of study treatment, without complete recovery.
•9.Receive any investigational drug treatment within 4 weeks of start of study treatment.
•10.Intercurrent infections uncontrolled.
•11.Patients with serious malabsortion syndrome.

发起方

Roche Farma, S.A.