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
- Conditions
- Advanced Pancreatic CancerMedDRA version: 9.1Level: LLTClassification code 10033609Term: Pancreatic carcinoma
- Registration Number
- EUCTR2007-001852-38-HU
- Lead Sponsor
- sanofi-aventis recherche & developpement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
•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
•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
- Secondary Outcome Measures
Name Time Method