S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen

Study Overview
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Brief Summary
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The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.

Official Title
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A Multicenter, Open-Label, Randomized Study Comparing Efficacy and Safety of S-1 as Single Agent Versus 5-FU Bolus for the Treatment of Patients With Metastatic Pancreatic Cancer Previously Treated With a Gemcitabine-Based Regimen

Conditions
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Pancreatic Neoplasm, Neoplasm Metastasis

Intervention / Treatment
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* Drug: S-1
* Drug: 5-Fluorouracil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas Metastatic disease previously treated with a gemcitabine-based regimen Exclusion Criteria: Locally advanced disease More than one prior chemotherapy-line for advanced pancreatic disease Prior treatment with fluoropyrimidines for advanced pancreatic cancer Eastern Cooperative Oncology Group (ECOG) performance status >or= 2 Poor kidney, liver or bone marrow functions Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study Unable to swallow capsules Hypersensitivity history to any of the constituents of the study medications or fluoropyrimidines Concurrent participation in another clinical trial or treatment with any other anticancer therapy The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 |
| --- | --- |
| Active Comparator: 5-Fluorouracil<br> | Drug: 5-Fluorouracil<br>* intravenous bolus<br>|
| Experimental: S-1<br> | Drug: S-1<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | every 6 weeks | 
| Overall Response Rate according to RECIST criteria |  | every 6 weeks | 
| Clinical Benefit assessed by Time to Symptoms Worsening (TTSW) |  | every 6 weeks | 

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