Avastin and Tarceva for Upper Gastrointestinal Cancers

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Erlotinib and bevacizumab have shown activity individually, as single drugs, or in combination with chemotherapy in upper gastro-intestinal cancers, including esophageal and gastro-esophageal adenocarcinomas, gastric cancer and pancreatic cancer. Biomarkers indicating an important role of EGF and VEGF have been found in these tumors, and in cholangiocarcinomas as well. There is promise that combined treatment with erlotinib and bevacizumab is active and tolerable in a broad range of upper gastro-intestinal cancers, justifying an experimental phase II-study of patients with these diagnoses, refractory or intolerant to standard systemic therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborator: Aarhus University Hospital
• Treatments: Bevacizumab; Erlotinib Hydrochloride

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