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


Phase 2
18 Years
N/A
Not Enrolling
Both
Unresectable, Locally Advanced, Metastatic

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

best overall response (according to RECIST 1.0)

Outcome Description:

overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded

Outcome Time Frame:

after an average of 2 months

Safety Issue:

No

Authority:

Austria: National Health and Medical Research Council

Study ID:

CCC 01

NCT ID:

NCT01216345

Start Date:

October 2006

Completion Date:

October 2009

Related Keywords:

  • Unresectable
  • Locally Advanced
  • Metastatic
  • Biliary Tract Neoplasms

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