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A Multicentre Phase II Trial of Gemcitabine and Oxaliplatin (GEMOX) in Patients With Biliary Tract Cancer

Phase 2
18 Years
Not Enrolling
Biliary Tract Neoplasms

Thank you

Trial Information

A Multicentre Phase II Trial of Gemcitabine and Oxaliplatin (GEMOX) in Patients With Biliary Tract Cancer

Inclusion Criteria

- 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

- 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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate response rate according to RECIST criteria

Principal Investigator

Jean-Philippe Aussel

Investigator Role:

Study Director

Investigator Affiliation:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

April 2003

Completion Date:

September 2006

Related Keywords:

  • Biliary Tract Neoplasms
  • Biliary Tract Neoplasms
  • Neoplasms