Continous treatment with bevacizumab in elderly patients with mCRC: an open label, single arm, prospective phase IV trial to evaluate outcome and safety of continuous bevacizumab treatment in combination with chemotherapy over disease progression - GRACE: Geriatric patients tReated with Avastin in CRC multiple linEs

Department of Oncology, Linköping University Hospital, Linköping, Sweden0 个研究点目标入组 48 人开始时间: 2014年12月9日最近更新: 2020年7月6日

适应症

试验速览

暂无简介。

•oUntreated metastatic colorectal carcinoma
•oAge = 70 years
•oMeasurable disease according to Response Evaluation Criteria in solid Tumors (RECIST) criteria
•oEastern Cooperative Oncology Group (ECOG) performance status =2
•oLife expectancy more than 3 months but not considered optimal candidate for treatment with combination chemotherapy with oxaliplatin or irinotecan
•oAdequate haematological, renal and liver function as measured by:
•?haemoglobin >90 g/L
•?absolute neutrophil count = 1,5 x 109/L
•?platelets = 100 x 109/L
•?bilirubin =1.5 × ULN
•?ALAT= 2.5 × ULN (<5 × ULN if liver metastases)
•?creatinine =1.5 × ULN
•?PK = 1.5
•?APTT <1.5 ULN
•?Urine dipstick of proteinuria <2+
•oTumor tissue available for biomarker analysis.
•oSigned written informed consent to the clinical study and translational research according to ICH/GCP and the local regulations will be obtained prior to any study specific screening procedures
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•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 100

•oAdjuvant therapy within 6 months
•oClinically significant (i.e. active) cardiovascular disease, e.g:
•?cerebrovascular accidents = 6 months prior to study enrolment
•?myocardial infarction = 6 months prior to study enrolment
•?unstable angina
•?congestive heart failure (NYHA Grade II or greater)
•?serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment.
•oSurgical procedure or significant traumatic injury within 28 days prior to first study treatment, or anticipation of need for major surgical procedure during the course of the study.
•oAny other serious or uncontrolled illness, which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial

发起方

Department of Oncology, Linköping University Hospital, Linköping, Sweden