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Cetuximab + Gemox in Biliary Tract Cancer

Sponsor
Association of Research on the Biology of Liver Tumors (Other)
Overall Status
Completed
CT.gov ID
NCT01216345
Collaborator
(none)
30
Enrollment
1
Location
36
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cetuximab + Gemcitabine + Oxaliplatin
 Phase 2

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)

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
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
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Oct 1, 2009

Outcome Measures

Primary Outcome Measures

  1. best overall response (according to RECIST 1.0) [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 Outcome Measures

  1. Safety of the treatment combination [approximately 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 KH Rudolfstiftung Vienna Austria 1030

Sponsors and Collaborators

  • Association of Research on the Biology of Liver Tumors

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01216345
Other Study ID Numbers:
  • CCC 01
First Posted:
Oct 7, 2010
Last Update Posted:
Oct 7, 2010
Last Verified:
Oct 1, 2010
Additional relevant MeSH terms:
Biliary Tract Neoplasms
Gemcitabine
Oxaliplatin
Cetuximab

Study Results

No Results Posted as of Oct 7, 2010