A phase II study of erlotinib and bevacizumab in patients with advanced upper gastrointestinal carcinomas, refractory or intolerable to standard systemic therapy

The Finsen Center, Rigshospitalet0 个研究点目标入组 63 人开始时间: 2006年4月25日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Histologically or cytologically verified upper gastro-intestinal carcinoma, including carcinomas of the esophagus, cardia, stomac, pancreas, gall bladder, and bile ducts of the following histological subtypes: adenocarcinoma, planocellular or squamous cell carcinoma, and anaplastic/high-grade or undifferentiated carcinoma.
•PS 0-2 (ECOG scale)
•Age over 18 years
•Life expectancy > 3 months
•Sufficient organ function, defined as:
•Platelets > 100 x 109/liter
•Leukocytes > 3,0 x 109/liter
•ACN > 1,5 x 109/liter
•ASAT and/or ALAT < 3 x upper normal limit
•Bilirubin < 1,5 x upper normal limit
•EDTA clearance > 45 ml/min
•APTT and INR < normal limit
•Fertile females must use oral contraceptive, IUD (intrauterine device) or preservatives. Fertile males must use preservatives.
•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

•Radiotherapy or chemotherapy within the last 4 weeks
•Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
•Any prior EGFR- or VEGFR-based therapy
•Any condition (medical, social, psychological), which would prevent adequate information and follow-up
•Tumor located close to major blood vessels and judged to possess a high risk of serious bleeding
•Any other active malignancy, except basal or squamous cell carcinoma of the skin, or carcinoma in situ
•Any significant cardiac disease (New York Heart Association Class II or greater), significant arrythmia, congestive heart failure, acute myocardial infarction within 6 months or unstable angina pectoris
•Clinically significant peripheral vascular disease
•Evidence of coagulapathy
•Use of ASA, NSAIDs or clopidogrel
•Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, anticipation of need for major surgical procedure during the curse of the study
•Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to treatment
•History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 month prior to treatment
•Any ongoing infection, uncontrolled diabetes mellitus, serious non-healing wound or ulcer
•Pregnancy or breast feeding
•Ongoing therapeutic anti-coagulation
•Hypertension with blood pressure > 150/100 mmHg

发起方

The Finsen Center, Rigshospitalet