S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen (S-1 Pancreas)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
61 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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