Clinical trial · Interventional
Cetuximab + Gemox in Biliary Tract Cancer
Cetuximab Plus Gemcitabine-Oxaliplatin (GEMOX) in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer: a Phase II Study
NCT01216345CI-TRIAL-00003998completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this prospective single-centre phase II study is to investigate the therapeutic efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin (GEMOX) in the palliative first line treatment of biliary tract cancer (BTC) patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced | — | UNRESOLVED | — |
| Metastatic | — | UNRESOLVED | — |
| Unresectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab + Gemcitabine + Oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- best overall response (according to RECIST 1.0)
- timeFrame
- after an average of 2 months
- description
- overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded
Secondary outcomes (1)
- measure
- Safety of the treatment combination
- timeFrame
- approximately 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically proven unresectable advanced or metastatic biliary tract cancer (including intrahepatic and extrahepatic CC and gallbladder cancer) * 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: * prior palliative treatment * 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)
References
Publications (2)
- RESULTGruenberger 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)
- DERIVEDGruenberger 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. PMID 21071270