The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of combination therapy with gemcitabine and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma.

Detailed Description
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Try a new drug association on this advanced cancer

Official Title
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National Trial Phase II to Study the Combination of Gemcitabine and Docetaxel in Patients With Locally Advanced or Metastatic Pancreatic or Biliary Adenocarcinoma That Cannot be Removed by Surgery

Conditions
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Pancreatic Neoplasms, Biliary Tract Neoplasms

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or older 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: No intracerebral or meningeal metastases 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: unique<br>Taxotère - Gemzar | Drug: Docetaxel<br>* Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines<br>* Other names: TAXOTERE;Drug: Gemcitabine<br>* Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines<br>* Other names: GEMZAR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit |  |  | 
| Progression-free survival |  |  | 
| Overall survival |  |  | 
| To evaluate the frequency and severity of the adverse events related to the combination of gemcitabine and docetaxel |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreas or biliary cancer