Sequential first line chemotherapy ECF (epirubicin + cisplatin + 5-fluoruracil) followed by DCF (docetaxel + cisplatin + 5-fluoruracil) in advanced/metastatic gastric cancer HER-2 negative: a phase II study - ECF-DCF

AZIENDA OSPEDALIERA SENESE0 个研究点开始时间: 2011年5月26日最近更新: 2013年10月7日

适应症

试验速览

暂无简介。

•- Patients with advanced or metastatic gastric cancer, not operable, at first diagnosis or relapsed after surgery, histologically confirmed, HER-2 negative - Age more than 18 years - Negative pregnancy test within 7 days of starting study treatment in pre-menopausal women - Written informed consent - ECOG performance status 0-3 - No prior chemotherapy or radiation therapy (allowed only if neoadjuvant or adjuvant therapy but without the use of ECF and DCF schedules) - Adequate hematological function: white blood cells >3500/mmc, neutrophils >1500/mmc, platelets >100000/mmc, hemoglobin >10 mg/dl - Adequate liver function: serum bilirubin = 1,5 x ULN; transaminases = 2,5 x ULN (in case liver metastases < 5 x ULN) - Adequate renal function: creatinine clearance > 90 ml/min - Adequate cardiac function - Not other relevant comorbidities - Life expectancy more than three months
•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

•- Other neoplastic diseases (excepted for cutaneous basalioma) - Pregnant or lactating women - Fertile men or women not using adequate contraception - Organ transplantation - Serious infection disease - Clinically significant cardiovascular disease - Immunodepression (for viral infection or genetic diseases) - Known hypersensitivity to any of the drugs in the study - Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.

发起方

AZIENDA OSPEDALIERA SENESE