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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Capecitabine; Fluorouracil; Gemcitabine

Criteria

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