Clinical trial · Interventional
Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib (Tarceva) in Advanced Biliary Tract Carcinoma
Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma
NCT01149122CI-TRIAL-00014531completedPhase 3ClinicalTrials.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 purpose of this study is to determine whether Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib (Tarceva) is effective in the treatment of unresectable, metastatic biliary tract carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable, Metastatic Biliary Tract Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine/Oxaliplatin | Drug | — | UNRESOLVED |
| Gemcitabine/Oxaliplatin with Erlotinib (Tarceva) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine/Oxaliplatin with Erlotinib
- interventionNames
- Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine/Oxaliplatin without Erlotinib
- interventionNames
- Drug: Gemcitabine/Oxaliplatin
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- every 6 weeks
Secondary outcomes (6)
- measure
- Safety profile
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. age ≥ 18 2. histologically or cytologically confirmed adenocarcinoma of biliary tract 3. unresectable or metastatic 4. ECOG performance status of 0\~2 5. measurable or evaluable lesion per RECIST criteria 6. adequate marrow, hepatic, renal and cardiac functions 7. no prior chemotherapy or molecularly targeted therapy for the advanced biliary carcinoma (prior adjuvant chemotherapy will be allowed if administered ≥ 6 months from the study entry) 8. provision of a signed written informed consent Exclusion Criteria: 1. severe co-morbid illness and/or active infections 2. pregnant or lactating women 3. active CNS metastases not controllable with radiotherapy or corticosteroids 4. known history of hypersensitivity to study drugs 5. prior exposure to EGFR tyrosine kinase inhibitor
References
Publications (2)
- DERIVEDKim ST, Jang KT, Lee SJ, Jang HL, Lee J, Park SH, Park YS, Lim HY, Kang WK, Park JO. Tumour shrinkage at 6 weeks predicts favorable clinical outcomes in a phase III study of gemcitabine and oxaliplatin with or without erlotinib for advanced biliary tract cancer. BMC Cancer. 2015 Jul 21;15:530. doi: 10.1186/s12885-015-1552-y. PMID 26189560
- DERIVEDLee J, Park SH, Chang HM, Kim JS, Choi HJ, Lee MA, Jang JS, Jeung HC, Kang JH, Lee HW, Shin DB, Kang HJ, Sun JM, Park JO, Park YS, Kang WK, Lim HY. Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2012 Feb;13(2):181-8. doi: 10.1016/S1470-2045(11)70301-1. Epub 2011 Dec 20. PMID 22192731