EXIBIT: Oxaliplatin in Biliary Tract Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00174564
First received: September 9, 2005
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Biliary Tract Neoplasms
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre Phase II Trial of Gemcitabine and Oxaliplatin (GEMOX) in Patients With Biliary Tract Cancer

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To evaluate response rate according to RECIST criteria

Secondary Outcome Measures:
  • To evaluate the progression-free survival in the ITT population
  • To investigate safety using NCI-CTC criteria version 2

Enrollment: 67
Study Start Date: April 2003
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174564

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jean-Philippe Aussel Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00174564     History of Changes
Other Study ID Numbers: C_8552
Study First Received: September 9, 2005
Last Updated: February 15, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014