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

Samsung Medical Center

Status and phase: Completed; Phase 3

Conditions: Unresectable, Metastatic Biliary Tract Carcinoma

Treatments: Drug: Gemcitabine/Oxaliplatin; Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)

Study type: Interventional

Funder types: Other

Identifiers

NCT01149122

2008-12-024

Details and patient eligibility

About

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.

Full description

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

Enrollment: 266 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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266 participants in 2 patient groups

Gemcitabine/Oxaliplatin with Erlotinib

Active Comparator group

Treatment:

Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)

Gemcitabine/Oxaliplatin without Erlotinib

Active Comparator group

Treatment:

Drug: Gemcitabine/Oxaliplatin