The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer
NCT ID: NCT00268840
Last Updated: 2011-06-30
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
45 participants
INTERVENTIONAL
2001-08-31
2006-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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unique
Taxotère - Gemzar
Docetaxel
Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines
Gemcitabine
Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines
Interventions
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Docetaxel
Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines
Gemcitabine
Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must sign informed consent prior to study entry
* Patients has Karnofsky performance status of more than 50%
* No prior chemotherapy
* Histologically or cytologically confirmed adenocarcinoma of the pancreas, locally advanced or metastatic disease or biliary cancer
* No previous radiotherapy for locally advanced or metastases.
* Hematopoietic: WBC \> 3000/mm2, Absolute neutrophile count \> 1500/mm2, Hemoglobin \> 9g/dl, Platelet count \> 100 000/mm2
Exclusion Criteria
* Pregnant
* Fertile patient must use effective contraception
* No other serious medical condition or illness that would preclude study participation
* Hepatic: Bilirubin greater than upper limit of normal(ULN) SGOT and SGPT \> 3.5 times upper limit of normal(ULN) alkaline phosphatase \> 6 times upper limit of normal(ULN)
* More than 30 days since prior investigational therapy
18 Years
60 Years
ALL
No
Sponsors
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ARCAGY/ GINECO GROUP
OTHER
Responsible Party
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ARCAGY-GINECO
Principal Investigators
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Chauvenet Laure, MD
Role: STUDY_CHAIR
ARCAGY/ GINECO GROUP
Locations
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Hôpital Hôtel Dieu
Paris, , France
Countries
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Other Identifiers
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RIO PANCREAS
Identifier Type: -
Identifier Source: org_study_id