Clinical trial NCT00602745: S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pancreatic Neoplasm
Neoplasm Metastasis
Keywords: pancreatic cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Taiho Pharmaceutical Co., Ltd.
First posted: 2008-01-28
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: study period
Secondary outcomes:
measure: Progression Free Survival
timeFrame: every 6 weeks
measure: Overall Response Rate according to RECIST criteria
timeFrame: every 6 weeks
measure: Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)
timeFrame: every 6 weeks
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Vienna
country: Austria
facility: Sanofi-Aventis Administrative Office
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: San José
country: Costa Rica
facility: Sanofi-Aventis Administrative Office
city: Horsholm
country: Denmark
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Athens
country: Greece
facility: Sanofi-Aventis Administrative Office
city: Mixco
country: Guatemala
facility: Sanofi-Aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi-Aventis Administrative Office
city: Netanya
country: Israel
facility: Sanofi-Aventis Administrative Office
city: Ocean Business Plaza
country: Panama
facility: Sanofi-Aventis Administrative Office
city: Lima
country: Peru
facility: Sanofi-Aventis Administrative Office
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
city: Megrine
country: Tunisia
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: