Phase II study of Oxaliplatin / Irinotecan / Cetuximab as first line therapy in locally advanced or metastatic gastric cancer

AGMT0 个研究点开始时间: 2006年11月13日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Signed informed consent
•Histologically proven gastric adenocarcinoma
•Measurable or evaluable, inoperable locally advanced or metastatic disease
•No previous palliative chemotherapy and/or immunotherapy
•Life expectancy of more than 3 months
•Age above 18 years
•WHO performance status ? 2 (Appendix 1)
•Negative pregnancy test (for female patients with reproduction potential and adequate contraception)
•Hematological status:
•Leucocytes ? 3 x 109/l
•Platelets ? 100 x 109/l
•Renal function:
•Serum creatinine: ? 1.5 x upper normal limit of the normal range of the laboratory Hepatic function:
•-Alkaline phosphatase: < 2.5 x upper normal limit of the normal range of the laboratory or < 5 x if hepatic metastases were present
•-total Bilirubin level ? 1.5 x upper normal limit of the normal range of the laboratory
•Baseline evaluations performed before treatment start: clinical and blood evaluations no more than 2 weeks prior to planned first course; tumoral assessment (CT scan or MRI, X- ray) no more than 4 weeks prior to planned first course
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years)
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•Women of child bearing potential not using a contraceptive method
•Pregnant or breast-feeding women
•Concomitant antitumoral treatment
•Adjuvant chemotherapy with Oxaliplatin and/or Irinotecan
•Prior history of chronic enteropathy, chronic diarrhea, unresolved bowel obstruction/subobstruction, or extensive abdominopelvic radiation therapy
•Participation in another clinical trial with any investigational drug within 30 days prior to inclusion
•Peripheral neuropathy (NCI CTC ? grade 1)
•Previous malignancy other than CRC in the last 5 years except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
•Legal incapacity or limited legal capacity
•Other uncontrolled serious non malignant diseases:
•Uncontrolled congestive heart failure, angina pectoris, hypertension or arrhythmias, hepatic disease, history of significant neurologic or psychiatric disorders, active infection

发起方

AGMT