Overview

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