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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
  Purpose

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 Intervention Phase
Unresectable
Locally Advanced
Metastatic
 Drug: Cetuximab + Gemcitabine + Oxaliplatin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Association of Research on the Biology of Liver Tumors:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Safety of the treatment combination [ Time Frame: approximately 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: October 2006
Study Completion Date: October 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216345

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

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)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Association of Research on the Biology of Liver Tumors
ClinicalTrials.gov Identifier: NCT01216345     History of Changes
Other Study ID Numbers: CCC 01
Study First Received: October 4, 2010
Last Updated: October 6, 2010
Health Authority: Austria: National Health and Medical Research Council

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Oxaliplatin
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 23, 2013