Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib (Tarceva) in Advanced Biliary Tract Carcinoma

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted18 and overOther2008-12-024

Trial Description


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.

Further Study Information

This is a phase III study of Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib in unresectable, metastatic biliary tract carcinoma.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Samsung Medical Center

    Ho yeong Lim, M.D,Ph.D, Principal Investigator

    Link to the current record.
    NLM Identifier NCT01149122 processed this data on October 20, 2014

    Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to