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EXIBIT: Oxaliplatin in Biliary Tract Cancer

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: September 9, 2005
Last updated: February 15, 2012
Last verified: February 2012
September 9, 2005
February 15, 2012
April 2003
September 2006   (Final data collection date for primary outcome measure)
To evaluate response rate according to RECIST criteria
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Complete list of historical versions of study NCT00174564 on Archive Site
  • To evaluate the progression-free survival in the ITT population
  • To investigate safety using NCI-CTC criteria version 2
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EXIBIT: Oxaliplatin in Biliary Tract Cancer
A Multicentre Phase II Trial of Gemcitabine and Oxaliplatin (GEMOX) in Patients With Biliary Tract Cancer

The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy in patients with advanced biliary tract cancer based on response rate measured by the RECIST unidimensional criteria.

Secondary objectives are : Progression free survival, overall survival and safety.

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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Biliary Tract Neoplasms
Drug: oxaliplatin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2006
September 2006   (Final data collection date for primary outcome measure)
  • Histologically proven, locally advanced or metastatic carcinoma of the biliary tract (gallbladder, intrahepatic bile ducts, extrahepatic bile ducts, ampula of Vater)
  • For intrahepatic bile ducts, if the diagnosis of biliary tract origin is not evident by imaging or surgical exploration, and so equivalent to liver metastasis with unknown primary site, inclusion is possible if:

    • unknown primary after an exhaustive search for the primary site (chest radiography- , thoracic and abdomino pelvic CT scan, colonoscopy, oesogastroduodenal endoscopy, PSA determination for men or mammography for women, and PET scan if possible).
    • histological examination compatible with adenocarcinoma of bile ducts with the immunostaining expression of cytokeratin : 7+, 20- and 19 +. (Shimonishi, 2000 ^22)
  • No prior chemotherapy for advanced disease (first line)
  • No radiation therapy within 4 weeks prior to the first gemcitabine administration.
  • Unidimensionally measurable disease.
  • For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
  • No known allergy to one of the study drugs
  • No prior malignancy
  • No CNS metastases
  • No peripheral neuropathy > grade 2
  • ECOG PS <=2
  • ANC > 1.5 X 10^9 /L
  • Platelets > 100 X 10^9 /L
  • Creatinine < 1.5 x ULN
  • SGPT (ALT) < 5 x ULN
  • Bilirubin < 2.5 x ULN (patients with jaundice or evidence of bile duct obstruction and in whom the biliary tree can be decompressed by endoscopic percutaneous endoprothesis, with subsequent reduction in bilirubin < 2.5 x ULN will be eligible for the study).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Jean-Philippe Aussel Sanofi
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP