Status:
COMPLETED
Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen
Lead Sponsor:
Sanofi
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT00417209
Start Date
December 1 2006
End Date
November 1 2009
Last Update
June 3 2016
Active Locations (21)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Diegem, Belgium
3
Sanofi-Aventis Administrative Office
São Paulo, Brazil
4
Sanofi-Aventis Administrative Office
Laval, Quebec, Canada