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
Conditions
Interventions
Product Name: Tarceva
Product Code: Erlotinib
Pharmaceutical Form: Coated tablet
Product Name: Avastin
Product Code: Bevacizumab
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
The Finsen Center, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 45 ml/min APTT and INR =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the median time to progression (TTP) and response rate (RR) of the combination of erlotinib and bevacizumab in patients with advanced upper gastro-intestinal carcinomas, refractory or intolerant to standard systemic therapy.;Secondary Objective: To determine safety, tolerability and toxicity. To determine median and overall survival (OS). To correlate efficacy of treatment with the expression of tumor markers obtained in serum (EFGR, bFGF, p-VEGF-A, and sVEGF-R2), in paraffin embedded tumor tissue (micro vessel density (MVD), and expression of VEGFR and EGFR, after immunostaining), and in fresh frozen tumor biopsies (micro array-based analyses of patterns of gene expression). ;Primary end point(s): median time to progression (TTP) and response rate (RR) safety, tolerability and toxicity. median and overall survival (OS). | — |
Countries
Denmark
Outcome results
None listed