Cetuximab + Gemox in Biliary Tract Cancer

Phase 2

Completed

• Conditions: Unresectable; Locally Advanced; Metastatic

• Registration Number: NCT01216345
• Lead Sponsor: Association of Research on the Biology of Liver Tumors

Brief Summary

The aim of this prospective single-centre phase II study is to investigate the therapeutic efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin (GEMOX) in the palliative first line treatment of biliary tract cancer (BTC) patients.

Detailed Description

Primary Objective(s) The primary objective of the study is to evaluate the best overall response of cetuximab in combination with gemcitabine and oxaliplatin (GEMOX) as first line treatment in patients with advanced or metastatic biliary tract cancer.

Secondary Objectives

The secondary objectives of this study are as follows:

* toxicity

* secondary resection rate

* progression-free survival (PFS)

* overall survival (OS)

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2008-10
• Study Completion: 2009-10
• Status Verified: 2010-10
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-06
• Last Update Submitted: 2010-10-06
• Study First Posted: 2010-10-07
• Last Update Posted: 2010-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• histologically or cytologically proven unresectable advanced or metastatic biliary tract cancer (including intrahepatic and extrahepatic CC and gallbladder cancer)
• age ≥ 18 years
• ECOG performance status ≤ 2
• bidimensionally measurable disease per RECIST criteria
• no prior chemotherapy or targeted therapy for advanced disease
• adequate bone marrow reserve (neutrophil count > 1500 /µL, platelet count > 100,000 /µL)
• adequate renal function (serum creatinine ≤ 1.5 x the upper limit of normal)
• adequate hepatic function (serum bilirubin <2.5 x the upper limit of normal (ULN) and serum transaminase level of ≤ 5 x ULN)
• written informed consent

Exclusion Criteria

• prior palliative treatment
• resectable disease
• brain metastases
• serious or uncontrolled concurrent medical illness
• pregnancy or nursing
• history of other malignancies with the exception of excised cervical or basal skin/squamous cell carcinoma
• peripheral neuropathy (grade > 1)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
best overall response (according to RECIST 1.0)	after an average of 2 months	overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded

Secondary Outcome Measures

Name	Time	Method
Safety of the treatment combination	approximately 6 months

Trial Locations

Locations (1)

KH Rudolfstiftung; 🇦🇹 Vienna, Austria