Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2003-04-30
2006-09-30
Brief Summary
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Secondary objectives are : Progression free survival, overall survival and safety.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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oxaliplatin
Eligibility Criteria
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Inclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Philippe Aussel
Role: STUDY_DIRECTOR
Sanofi
Other Identifiers
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C_8552
Identifier Type: -
Identifier Source: org_study_id
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