CompletedPhase 2

Avastin and Tarceva for Upper Gastrointestinal Cancers

Denmark126 participantsStarted 2006-06

Plain-language 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.

Who can participate

Age range

18 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objective response by RECIST criteria

Timeframe: From time of treatment start to response evaluation

Time to progression

Timeframe: 1 year

Trial details

NCT IDNCT00350753

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-06

View on ClinicalTrials.gov More Cholangiocarcinoma trials