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

Phase 3

Completed

• Conditions: Unresectable, Metastatic Biliary Tract Carcinoma
• Interventions: Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva); Drug: Gemcitabine/Oxaliplatin

• Registration Number: NCT01149122
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-06
• Last Update Submitted: 2014-05-14
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine/Oxaliplatin with Erlotinib	Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)	-
Gemcitabine/Oxaliplatin without Erlotinib	Gemcitabine/Oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	every 6 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of