Full Text View
Tabular View
No Study Results Posted
Related Studies
Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen (PAPRIKA)
This study is ongoing, but not recruiting participants.
Study NCT00417209   Information provided by Sanofi-Aventis
First Received: December 28, 2006   Last Updated: July 7, 2009   History of Changes

December 28, 2006
July 7, 2009
December 2006
July 2009   (final data collection date for primary outcome measure)
overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause [ Time Frame: study period ] [ Designated as safety issue: No ]
The primary efficacy endpoint is overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause.
Complete list of historical versions of study NCT00417209 on ClinicalTrials.gov Archive Site
Progression free survival (PFS); Overall Response Rate (proportion of patients with confirmed RECIST-defined complete response (CR) or partial response (PR); clinical benefit based on the measurement of tumor related symptoms; [ Time Frame: study period ] [ Designated as safety issue: No ]
Progression free survival (PFS); Overall Response Rate (proportion of patients with confirmed RECIST-defined complete response (CR) or partial response (PR); clinical benefit based on the measurement of tumor related symptoms;
 
Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen
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

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 III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Pancreatic Neoplasms
  • Drug: larotaxel (XRP9881)
  • Drug: 5-Fluorouracil
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
400
October 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   Finland,   Germany,   Hungary,   India,   Italy,   Mexico,   Norway,   Peru,   Poland,   Russian Federation,   Slovakia,   Spain,   Turkey,   United Kingdom
 
NCT00417209
ICD Study Director, sanofi-aventis
EFC6596, EUDRACT: 2006-003086-14
Sanofi-Aventis
 
Study Director: ICD Sanofi-Aventis
Sanofi-Aventis
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP