Bevacizumab+folfiri in untreated patients with advanced colorectal cancer. A phase II multicenter study of the Gruppo Oncologico dell'Italia Meridionale. (GOIM). - Bevacizumab+folfiri in untreated patients with advanced colorectal cance

GOIM GRUPPO ONCOLOGICO MERIDIONALE0 个研究点开始时间: 2007年6月26日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Locally advanced or metastatic non-resectable colorectal cancer
•Histologically confirmed adenocarcinoma
•Presence of at least one measurable lesion
•Age >= 18 years and < 75 years
•Karnofsky performance status of > 70 at study entry
•Life expectancy of > 3 months
•Laboratory data:
•Neutrophils >= 1.5 x 109/L, platelets >= 100 x 109/L, hemoglobin >= 9 g/dl
•ALAT and ASAT <= 2.5 x ULN (< 5 x ULN if liver metastases are present)
•Total Bilirubin <= 1.5 x ULN
•Serum creatinine <= 1.5 x ULN
•Effective contraception in female patients at risk of conception/absence of pregnancy or breastfeeding
•Signed written informed consent.
•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

•Brain metastasis
•Previous chemotherapy for locally advanced or metastatic colorectal (adjuvant therapy without irinotecan is allowed if recurrence is documented > 6 months after the end of adjuvant treatment)
•Radiotherapy within 4 weeks prior to study entry
•Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months
•Acute or subacute intestinal occlusion or history of the inflammatory bowel disease
•Patients with peripheral neuropathy (NCI CTC >1)
•Known drug abuse/alcohol
•Legal incapacity or limited legal capacity
•Medical or psychological condition which, in the opinion of the investigator, would not enable the patient to complete the study or knowingly sign the Informed Consent
•Women who are pregnant or breastfeeding
•Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (patients with a previous malignancy but with no evidence of disease for > 5 years will be allowed to enter the trial)

发起方

GOIM GRUPPO ONCOLOGICO MERIDIONALE