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NCT Number: NCT01216345

Cetuximab + Gemox in Biliary Tract Cancer

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.

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Key information

Conditions

Unresectable Locally Advanced Metastatic Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

KH Rudolfstiftung

Vienna, 1030, Austria

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cetuximab + Gemcitabine + Oxaliplatin

Drug

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 outcomes

  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 outcomes

  1. Safety of the treatment combination

    Time frame: approximately 6 months

Sponsors and collaborators

Lead sponsor

Association of Research on the Biology of Liver Tumors

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Oct 7, 2010
Registry last updated
Oct 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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