CholangiocarcinomaPhase 2NCT00350753
Avastin and Tarceva for Upper Gastrointestinal Cancers
A Phase 2 study testing Erlotinib and bevacizumab in people with Cholangiocarcinoma and Gallbladder Cancer, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Cholangiocarcinoma, Gallbladder Cancer
- What is being tested?
- Erlotinib and bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 3 sitesDenmark
- Study dates
- Jun 2006to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Århus Sygehus
Aarhus, 8000 C
Rigshospitalet
Copenhagen, 2100
Odense University Hospital
Odense, 5000
About this study
Official title: A Phase II Study of Erlotinib and Bevacizumab in Patients With Advanced Upper Gastrointestinal Carcinomas, Refractory or Intolerable to Standard Systemic Therapy
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.
Read the 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 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).
Treatment:
Bevacizumab (AvastinÒ) will be given intravenously at 10 mg/kg every other week.
Erlotinib is given as an orally daily dose and most be taken at least one hour before or two hours after ingestion of food.
- Conditions
- Cholangiocarcinoma, Gallbladder Cancer
- Being tested
- Erlotinib and bevacizumab
- Keywords
- Cholangiocarcinoma
- Medical subject headings
- Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib and bevacizumabDrug
Erlotonib 150 mg daily bevacizumab 10 mg/kg every 14 days
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib and bevacizumab | Experimental | Not described Receives: Drug: Erlotinib and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response by RECIST criteria
Measured: From time of treatment start to response evaluation
Time to progression
Measured: 1 year
Secondary outcomes (3)
Toxicity evaluated by NCI-CTCae version 3.0
Measured: 1 year
Survival
Measured: 1 year
Biomarkers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Investigators
- Ulrik Lassen, MD., PH.D., Principal investigator, Rigshospitalet, Dept. of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350753
- Sponsor's protocol ID
- EB-UGI-01
- Other IDs
- 2006-001308-35
- Status last verified
- Jul 2009
- First submitted
- 10 Jul 2006
- Last updated
- 15 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Erlotinib and Bevacizumab in Patients With Advanced Upper Gastrointestinal Carcinomas, Refractory or Intolerable to Standard Systemic Therapy
- ClinicalTrials.gov ID
- NCT00350753
- Acronym / sponsor ID
- EB-UGI-01
- Conditions
- Cholangiocarcinoma, Gallbladder Cancer
- Keywords
- Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Jun 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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).
Treatment:
Bevacizumab (AvastinÒ) will be given intravenously at 10 mg/kg every other week.
Erlotinib is given as an orally daily dose and most be taken at least one hour before or two hours after ingestion of food.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib and bevacizumab | Experimental | Drug: Erlotinib and bevacizumab |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erlotinib and bevacizumabErlotonib 150 mg daily bevacizumab 10 mg/kg every 14 days | Drug | Erlotinib and bevacizumab |
Primary outcome
Objective response by RECIST criteria
Time frame: From time of treatment start to response evaluation
Time to progression
Time frame: 1 year
3 secondary outcomes
Toxicity evaluated by NCI-CTCae version 3.0
Time frame: 1 year
Survival
Time frame: 1 year
Biomarkers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik Lassen, MD., PH.D. principal investigator
Rigshospitalet, Dept. of Oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib and bevacizumab in people with Cholangiocarcinoma and Gallbladder Cancer, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response by RECIST criteria (time frame: From time of treatment start to response evaluation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2009.