Cetuximab + Gemox in Biliary Tract Cancer

Association of Research on the Biology of Liver Tumors30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Enrollment

Conditions

Unresectable Locally Advanced Metastatic

Interventions

Cetuximab + Gemcitabine + OxaliplatinDRUG

Cetuximab 500mg/m2, iv every two weeks Gemcitabine 1000mg/m2, iv every two weeks Oxaliplatin 100mg/m2, iv every two weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

KH Rudolfstiftung

Vienna, Austria

Outcomes

Primary Outcomes

best overall response (according to RECIST 1.0)

overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded

Time frame: after an average of 2 months

Secondary Outcomes

Safety of the treatment combination

Time frame: approximately 6 months

Data from ClinicalTrials.gov

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