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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
Not Enrolling
Both
Pancreatic Neoplasms

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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 OfficeBridgewater, New Jersey  08807