Status:
COMPLETED
Avastin and Tarceva for Upper Gastrointestinal Cancers
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Aarhus University Hospital
Conditions:
Cholangiocarcinoma
Gallbladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 adenocar...
Detailed Description
Primary 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 carcinom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00350753
Start Date
June 1 2006
End Date
June 1 2009
Last Update
July 15 2009
Active Locations (3)
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1
Århus Sygehus
Aarhus, Denmark, 8000 C
2
Rigshospitalet
Copenhagen, Denmark, 2100
3
Odense University Hospital
Odense, Denmark, 5000