A Multicenter, Open-Label, Randomized Study comparing Efficacy and Safety of S-1 as single agent at 30 mg/m2 BID versus 5-FU Bolus Infusion for the Treatment of Patients with Advanced Pancreatic Cancer previously treated with a Gemcitabine Based-Regimen - S-1 Pancreas

Phase 1

Conditions: Advanced Pancreatic Cancer
MedDRA version: 9.1Level: LLTClassification code 10033609Term: Pancreatic carcinoma

Registration Number: EUCTR2007-001852-38-GR

Lead Sponsor: sanofi-aventis recherche & developpement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

•Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas.
•Metastatic disease previously treated with a gemcitabine-based regimen (gemicitabine-based regimens which included erlotinib are permitted) as adjuvant chemotherapy (disease free interval must be less than 6 months) or progression on a gemcitabine-based regimen for metastatic disease. Patients treated in addition with prior chemo-radiation to the primary pancreatic tumor, in which the chemotherapeutic agent was used as a radio-sensitizing agent, are eligible.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Prior therapy:
?More than one prior chemotherapy-line for advanced pancreatic disease.
•General conditions:
?Eastern Cooperative Oncology Group (ECOG) performance status (PS) =2,
?Neutrophils <1.5 x 109/L, Hgb <9 g/dL, Platelets <100 x 109/L
?Serum total bilirubin >1.5 x Upper limit of normal (ULN),
?AST (SGOT)/ ALT (SGPT) >2.5 x ULN. If liver function abnormalities are due to underlying liver metastasis, then AST (SGOT) and ALT (SGPT) may be >5 times ULN.
?Serum creatinine >1.5 x ULN and Calculated creatinine clearance <60 ml/min (based on serum creatinine/Cockroft-Gault formula).
•Prior or current history:
?Known dihydropyrimidine dihydrogenase deficiency.
?Known hypersensitivity history to any of the constituents of the study medications (Tegafur, Gimeracil, or Oteracil potassium), or to fluoropyrimidines.
?Active infection requiring systemic antibiotic or anti-fungal medication; and known human immunodeficiency virus (HIV) infection requiring treatment or acquired immunodeficiency-syndrome (AIDS)-related illness.
•Concomitant treatments:
?Concurrent treatment with drugs interacting with S-1
?Concurrent participation in another clinical trial or treatment with any other anticancer therapy
•Others:
?Unwilling or unable to sign informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: To compare:<br>•Progression Free Survival (PFS),<br>•Overall Response Rate (ORR) according to RECIST criteria (Appendix A), <br>•Clinical Benefit assessed by Time to Symptoms Worsening (TTSW) and improvement in tumor related symptoms,<br>To assess:<br>•Overall Safety,<br>•Pharmacokinetics of S-1<br>;Primary end point(s): •Overall survival (OS) will be assessed from the date of randomization to death.

Secondary Outcome Measures

Name	Time	Method