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

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

Official Title
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Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma

Conditions
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Unresectable, Metastatic Biliary Tract Carcinoma

Intervention / Treatment
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* Drug: Gemcitabine/Oxaliplatin
* Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 histologically or cytologically confirmed adenocarcinoma of biliary tract unresectable or metastatic ECOG performance status of 0 2 measurable or evaluable lesion per RECIST criteria adequate marrow, hepatic, renal and cardiac functions 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) provision of a signed written informed consent Exclusion Criteria: severe co-morbid illness and/or active infections pregnant or lactating women active CNS metastases not controllable with radiotherapy or corticosteroids known history of hypersensitivity to study drugs prior exposure to EGFR tyrosine kinase inhibitor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gemcitabine/Oxaliplatin with Erlotinib<br> | Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)<br>* GEMOX + Tarceva: (Gemcitabine 1000 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q 2weeks; Tarceva 100 mg qd<br>|
| Active Comparator: Gemcitabine/Oxaliplatin without Erlotinib<br> | Drug: Gemcitabine/Oxaliplatin<br>* GEMOX: (Gemcitabine 100 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q (every) 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | every 6 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unresectable, metastatic biliary tract carcinoma, Gemcitabine/Oxaliplatin (GEMOX), Erlotinib