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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 4, 2010
Last Updated Date	October 6, 2010
Start Date ^ICMJE	October 2006
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 6, 2010)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01216345 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 6, 2010)	Safety of the treatment combination [ Time Frame: approximately 6 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cetuximab + Gemox in Biliary Tract Cancer
Official Title ^ICMJE	Cetuximab Plus Gemcitabine-Oxaliplatin (GEMOX) in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer: a Phase II Study
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)
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Primary Purpose: Treatment
Condition ^ICMJE	Unresectable Locally Advanced Metastatic
Intervention ^ICMJE	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
Study Arm (s)	Not Provided
Publications *	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) 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. Epub 2010 Nov 9.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	October 2009
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria

Administrative Information
NCT Number ^ICMJE	NCT01216345
Other Study ID Numbers ^ICMJE	CCC 01
Has Data Monitoring Committee	No
Responsible Party	Association of Research on the Biology of Liver Tumors
Study Sponsor ^ICMJE	Association of Research on the Biology of Liver Tumors
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Association of Research on the Biology of Liver Tumors
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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