EXIBIT: Oxaliplatin in Biliary Tract Cancer

Biliary Tract Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174564
• Other study ID #: C_8552
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: February 15, 2012
• Start date: April 2003
• Est. completion date: September 2006

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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).

Study Design

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

Related Conditions & MeSH terms

• Biliary Tract Neoplasms

Intervention

Drug:
• oxaliplatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate response rate according to RECIST criteria
Secondary	To evaluate the progression-free survival in the ITT population
Secondary	To investigate safety using NCI-CTC criteria version 2