EXIBIT: Oxaliplatin in Biliary Tract Cancer
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00174564
First received: September 9, 2005
Last updated: February 15, 2012
Last verified: February 2012
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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 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 Neoplasms Digestive System Neoplasms Neoplasms by Site Biliary Tract Diseases |
Digestive System Diseases Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013