Clincosm LogoSign in Get a demo

EXIBIT: Oxaliplatin in Biliary Tract Cancer

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00174564
Collaborator
(none)
67
Enrollment
41
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicentre Phase II Trial of Gemcitabine and Oxaliplatin (GEMOX) in Patients With Biliary Tract Cancer
Study Start Date :
Apr 1, 2003
Actual Primary Completion Date :
Sep 1, 2006
Actual Study Completion Date :
Sep 1, 2006

Outcome Measures

Primary Outcome Measures

  1. To evaluate response rate according to RECIST criteria []

Secondary Outcome Measures

  1. To evaluate the progression-free survival in the ITT population []

  2. To investigate safety using NCI-CTC criteria version 2 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

  • 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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Jean-Philippe Aussel, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174564
Other Study ID Numbers:
  • C_8552
First Posted:
Sep 15, 2005
Last Update Posted:
Feb 17, 2012
Last Verified:
Feb 1, 2012
Additional relevant MeSH terms:
Biliary Tract Neoplasms
Oxaliplatin

Study Results

No Results Posted as of Feb 17, 2012