Cetuximab + Gemox in Biliary Tract Cancer

Locally Advanced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216345
• Other study ID #: CCC 01
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2010
• Last updated: October 6, 2010
• Start date: October 2006
• Est. completion date: October 2009

Study information

• Verified date: October 2010
• Source: Association of Research on the Biology of Liver Tumors
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced
• Metastatic
• Unresectable

Intervention

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

Locations

Country	Name	City	State
Austria	KH Rudolfstiftung	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Association of Research on the Biology of Liver Tumors

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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 458

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	after an average of 2 months	No
Secondary	Safety of the treatment combination		approximately 6 months	Yes