Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2006-10-31
2009-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Secondary Objectives
The secondary objectives of this study are as follows:
* toxicity
* secondary resection rate
* progression-free survival (PFS)
* overall survival (OS)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cetuximab + Gemcitabine + Oxaliplatin
Cetuximab 500mg/m2, iv every two weeks Gemcitabine 1000mg/m2, iv every two weeks Oxaliplatin 100mg/m2, iv every two weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age ≥ 18 years
* ECOG performance status ≤ 2
* bidimensionally measurable disease per RECIST criteria
* no prior chemotherapy or targeted therapy for advanced disease
* adequate bone marrow reserve (neutrophil count \> 1500 /µL, platelet count \> 100,000 /µL)
* adequate renal function (serum creatinine ≤ 1.5 x the upper limit of normal)
* adequate hepatic function (serum bilirubin \<2.5 x the upper limit of normal (ULN) and serum transaminase level of ≤ 5 x ULN)
* written informed consent
Exclusion Criteria
* resectable disease
* brain metastases
* serious or uncontrolled concurrent medical illness
* pregnancy or nursing
* history of other malignancies with the exception of excised cervical or basal skin/squamous cell carcinoma
* peripheral neuropathy (grade \> 1)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Association of Research on the Biology of Liver Tumors
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Association of Research on the Biology of Liver Tumors
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
KH Rudolfstiftung
Vienna, , Austria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gruenberger B, Schueller J, et al: K-ras status and response in patients with advanced or metastatic cholangiocarcinoma treated with cetuximab plus gemcitabine-oxaliplatin (GEMOX): a single center phase II study J Clin Oncol 27:15s, 2009 (suppl; abstr 4586)
Gruenberger B, Schueller J, Heubrandtner U, Wrba F, Tamandl D, Kaczirek K, Roka R, Freimann-Pircher S, Gruenberger T. Cetuximab, gemcitabine, and oxaliplatin in patients with unresectable advanced or metastatic biliary tract cancer: a phase 2 study. Lancet Oncol. 2010 Dec;11(12):1142-8. doi: 10.1016/S1470-2045(10)70247-3. Epub 2010 Nov 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCC 01
Identifier Type: -
Identifier Source: org_study_id