Advanced Pancreatic Cancer MedDRA version: 9.1 Level: LLT Classification code 10033609 Term: Pancreatic carcinoma
Conditions
Interventions
Trade Name: TS-1
Product Name: S-1
Product Code: S-1
Pharmaceutical Form: Capsule*
INN or Proposed INN: Tegafur
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Sponsors
sanofi-aventis recherche & developpement
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare: • Progression Free Survival (PFS), • Overall Response Rate (ORR) according to RECIST criteria (Appendix A), • Clinical Benefit assessed by Time to Symptoms Worsening (TTSW) and improvement in tumor related symptoms, To assess: • Overall Safety, • Pharmacokinetics of S-1 ;Primary end point(s): • Overall survival (OS) will be assessed from the date of randomization to death.;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 | — |
Countries
Austria, Denmark, France, Greece, Hungary, Sweden
Outcome results
None listed