EXIBIT: Oxaliplatin in 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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Key information

Conditions

Biliary Tract Neoplasms Biliary Tract Diseases Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Oxaliplatin

Drug

Primary outcomes

To evaluate response rate according to RECIST criteria

Secondary outcomes

To evaluate the progression-free survival in the ITT population
To investigate safety using NCI-CTC criteria version 2

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2006
First posted: Sep 15, 2005
Registry last updated: Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed