Cetuximab + Gemox in Biliary Tract Cancer

This study has been completed.
Sponsor:
Information provided by:
Association of Research on the Biology of Liver Tumors
ClinicalTrials.gov Identifier:
NCT01216345
First received: October 4, 2010
Last updated: October 6, 2010
Last verified: October 2010

October 4, 2010
October 6, 2010
October 2006
October 2008   (final data collection date for primary outcome measure)
best overall response (according to RECIST 1.0) [ Time Frame: after an average of 2 months ] [ Designated as safety issue: No ]
overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded
Same as current
Complete list of historical versions of study NCT01216345 on ClinicalTrials.gov Archive Site
Safety of the treatment combination [ Time Frame: approximately 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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)
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
  • Unresectable
  • Locally Advanced
  • Metastatic
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2009
October 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01216345
CCC 01
No
Association of Research on the Biology of Liver Tumors
Association of Research on the Biology of Liver Tumors
Not Provided
Not Provided
Association of Research on the Biology of Liver Tumors
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP