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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01216345
Other study ID # CCC 01
Secondary ID
Status Completed
Phase Phase 2
First received October 4, 2010
Last updated October 6, 2010
Start date October 2006
Est. completion date October 2009

Study information

Verified date October 2010
Source Association of Research on the Biology of Liver Tumors
Contact n/a
Is FDA regulated No
Health authority Austria: National Health and Medical Research Council
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 2009
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria KH Rudolfstiftung Vienna

Sponsors (1)

Lead Sponsor Collaborator
Association of Research on the Biology of Liver Tumors

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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 458

Outcome

Type Measure Description Time frame Safety issue
Primary 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 after an average of 2 months No
Secondary Safety of the treatment combination approximately 6 months Yes
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