Clinical trial NCT01216345: Cetuximab + Gemox in Biliary Tract Cancer
Official title: Cetuximab Plus Gemcitabine-Oxaliplatin (GEMOX) in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer: a Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unresectable
Locally Advanced
Metastatic
Lead sponsor: Association of Research on the Biology of Liver Tumors
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility 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)

Primary outcomes:
measure: best overall response (according to RECIST 1.0)
timeFrame: after an average of 2 months
Secondary outcomes:
measure: Safety of the treatment combination
timeFrame: approximately 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: KH Rudolfstiftung
Study officials:
References:
citation: Gruenberger B, Schueller J, et al: K-ras status and response in patients with advanced or metastatic cholangiocarcinoma treated with cetuximab plus gemcitabine-oxaliplatin (GEMOX): a single center phase II study J Clin Oncol 27:15s, 2009 (suppl; abstr 4586)
citation: Gruenberger B, Schueller J, Heubrandtner U, Wrba F, Tamandl D, Kaczirek K, Roka R, Freimann-Pircher S, Gruenberger T. Cetuximab, gemcitabine, and oxaliplatin in patients with unresectable advanced or metastatic biliary tract cancer: a phase 2 study. Lancet Oncol. 2010 Dec;11(12):1142-8. doi: 10.1016/S1470-2045(10)70247-3. Epub 2010 Nov 9.