Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen

A Randomized, Open Label Multi-Center Study Of Single Agent Larotaxel (XRP9881) Compared To Continuous Administration of 5-FU For The Treatment Of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen

The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.

Inclusion Criteria:

• Advanced (non operable in a curative intent, locally recurrent or metastatic disease) Cytologically or histologically proven epithelial cancer (adenocarcinoma) of the exocrine pancreas.
• Patient must be previously treated with a systemic gemcitabine based regimen
• Adequate bone marrow, kidney and liver functions

Exclusion Criteria:

• ECOG performance status (PS) of 2-3-4.
• Prior locoregional radiotherapy for pancreatic cancer.
• Symptomatic brain metastases or leptomeningeal disease.
• Any serious intercurrent infections, uncontrolled cardiac or gastro-intestinal diseases.
• Other concurrent malignancy
• Other protocol-defined exclusion/inclusion criteria may apply