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

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

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.

Try a new drug association on this advanced cancer

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