Trial | NCT01216345  Report issue

Title

Cetuximab + Gemox in Biliary Tract Cancer
Cetuximab Plus Gemcitabine-Oxaliplatin (GEMOX) in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer: a Phase II Study

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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 Started
Oct 31
2006
Primary Completion
Oct 31
2008
Study Completion
Oct 31
2009
Last Update
Oct 07
2010
Estimate

Drug Cetuximab + Gemcitabine + Oxaliplatin

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

  • Other names: Erbitux, GEMOX

Criteria 

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)
No Results Posted