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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01149122

Enrollment

266

Registered

2010-06-23

Start date

2009-01-31

Completion date

2012-06-30

Last updated

2014-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable, Metastatic Biliary Tract Carcinoma

Keywords

unresectable, metastatic biliary tract carcinoma, Gemcitabine/Oxaliplatin (GEMOX), Erlotinib

Brief summary

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.

Detailed description

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

Interventions

DRUGGemcitabine/Oxaliplatin

GEMOX: (Gemcitabine 100 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q (every) 2 weeks

DRUGGemcitabine/Oxaliplatin with Erlotinib (Tarceva)

GEMOX + Tarceva: (Gemcitabine 1000 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q 2weeks; Tarceva 100 mg qd

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	every 6 weeks

Secondary

Measure	Time frame
Response rate	24 months
Duration of response	24 months
Safety profile	24 months
Overall survival	24 months
Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses	24 months
Time to progression	24 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026