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Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen (PAPRIKA)

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ClinicalTrials.gov Identifier: NCT00417209
Recruitment Status : Completed
First Posted : December 29, 2006
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

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 pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: Larotaxel (XRP9881) Drug: 5-Fluorouracil Drug: Capecitabine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Larotaxel (XRP9881) Drug: Larotaxel (XRP9881)
administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
Active Comparator: 5-Fluorouracil or capecitabine
Each Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site.
Drug: 5-Fluorouracil
administered as IV infusion from Day 1 to Day 4
Drug: Capecitabine
administered orally from Day 1 to Day 14 q3w



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417209


  Show 21 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00417209     History of Changes
Other Study ID Numbers: EFC6596
EUDRACT: 2006-003086-14
First Posted: December 29, 2006    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2016

Keywords provided by Sanofi:
advanced pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs