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Cetuximab + Gemox in Biliary Tract Cancer

Primary Purpose

Unresectable, Locally Advanced, Metastatic

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Cetuximab + Gemcitabine + Oxaliplatin
Sponsored by
Association of Research on the Biology of Liver Tumors
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • KH Rudolfstiftung

Outcomes

Primary Outcome Measures

best overall response (according to RECIST 1.0)
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

Full Information

First Posted
October 4, 2010
Last Updated
October 6, 2010
Sponsor
Association of Research on the Biology of Liver Tumors
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1. Study Identification

Unique Protocol Identification Number
NCT01216345
Brief Title
Cetuximab + Gemox in Biliary Tract Cancer
Official Title
Cetuximab Plus Gemcitabine-Oxaliplatin (GEMOX) in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer: a Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Association of Research on the Biology of Liver Tumors

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable, Locally Advanced, Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cetuximab + Gemcitabine + Oxaliplatin
Other Intervention Name(s)
Erbitux, GEMOX
Intervention Description
Cetuximab 500mg/m2, iv every two weeks Gemcitabine 1000mg/m2, iv every two weeks Oxaliplatin 100mg/m2, iv every two weeks
Primary Outcome Measure Information:
Title
best overall response (according to RECIST 1.0)
Description
overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded
Time Frame
after an average of 2 months
Secondary Outcome Measure Information:
Title
Safety of the treatment combination
Time Frame
approximately 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
KH Rudolfstiftung
City
Vienna
ZIP/Postal Code
1030
Country
Austria

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
result
PubMed Identifier
21071270
Citation
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. doi: 10.1016/S1470-2045(10)70247-3. Epub 2010 Nov 9.
Results Reference
derived

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Cetuximab + Gemox in Biliary Tract Cancer

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