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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasms
Both
Pancreatic Neoplasms
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause
Outcome Time Frame:
study period
Safety Issue:
No
Principal Investigator
ICD
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Food and Drug Administration
Study ID:
EFC6596
NCT ID:
NCT00417209
Start Date:
December 2006
Completion Date:
November 2009
Related Keywords:
- Pancreatic Neoplasms
- advanced pancreatic cancer
- Neoplasms
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater, New Jersey 08807 |
