Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Unfortunately, other Phase III clinical Study (GEM+S-1 vs GEM vs S-1) have been started in Japan.
To assess the usefulness of Gemcitabine plus S-1 therapy based on the antitumor effect and survival period. By performing a phase I/II study of this combination in patients with inoperable or with postoperative pancreatic cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer|
- Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting.
- Determine the clinical response rate with Recommended dose in Phase II setting.
- Determine the clinical response rate of patients in Phase I setting.
- Determine the MST(Median Survival Time) and DFS(Disease Free Survival) in Phase II setting.
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||December 2007|
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV Pancreatic cancer given gemcitabine plus S-1. The usefulness of this regimens as 1st line therapy for pancreatic cancer was evaluated by the disease-free survival(DFS), median survival time (MST), incidence and severity of adverse event.
|Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)|
|Sapporo, Hokkaido, Japan, 060-8638|
|Study Chair:||Masahiro Asaka, MD, PhD||Hokkaido Gastrointestinal Cancer Study Group|