Avastin and Tarceva for Upper Gastrointestinal Cancers
Cholangiocarcinoma, Gallbladder Cancer
About this trial
This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Cholangiocarcinoma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically verified carcinoma of the gall bladder or bile ducts. PS 0-1 (ECOG scale) Age > 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. Exclusion Criteria: 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 coagulopathy 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 o 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
Sites / Locations
- Rigshospitalet
- Odense University Hospital
- Århus Sygehus
Arms of the Study
Arm 1
Experimental
Erlotinib and bevacizumab