EXIBIT: Oxaliplatin in Biliary Tract Cancer

Sanofi

Status and phase

Completed

Phase 2

Conditions

Biliary Tract Neoplasms

Treatments

Drug: oxaliplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00174564

C_8552

Details and patient eligibility

About

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.

Enrollment

67 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 ^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).