Cetuximab + Gemox in Biliary Tract Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01216345
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : October 7, 2010
Information provided by:
Association of Research on the Biology of Liver Tumors

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.

Condition or disease Intervention/treatment Phase
Unresectable Locally Advanced Metastatic Drug: Cetuximab + Gemcitabine + Oxaliplatin Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Cetuximab Plus Gemcitabine-Oxaliplatin (GEMOX) in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer: a Phase II Study
Study Start Date : October 2006
Primary Completion Date : October 2008
Study Completion Date : October 2009

Intervention Details:
    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

Primary Outcome Measures :
  1. best overall response (according to RECIST 1.0) [ Time Frame: after an average of 2 months ]
    overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded

Secondary Outcome Measures :
  1. Safety of the treatment combination [ Time Frame: approximately 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01216345

KH Rudolfstiftung
Vienna, Austria, 1030
Sponsors and Collaborators
Association of Research on the Biology of Liver Tumors

Publications of Results:
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)

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Association of Research on the Biology of Liver Tumors Identifier: NCT01216345     History of Changes
Other Study ID Numbers: CCC 01
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: October 7, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs