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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Drug: Larotaxel (XRP9881)
* Drug: 5-Fluorouracil
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Larotaxel (XRP9881)<br> | Drug: Larotaxel (XRP9881)<br>* administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)<br>|
| Active Comparator: 5-Fluorouracil or capecitabine<br>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<br>* administered as IV infusion from Day 1 to Day 4<br>Drug: Capecitabine<br>* administered orally from Day 1 to Day 14 q3w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause |  | study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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; |  | study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced pancreatic cancer