NCT00652054

Phase 2 Study of S-1 as 2nd Line Therapy in Metastatic Pancreatic Cancer

An Open-Label, Non-Randomized, Multicenter, Two-Stage, Phase 2 Study of S-1 as 2nd Line Therapy for Patients With Metastatic Pancreatic Cancer Who Have Previously Received 1st Line Treatment With a Gemcitabine Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether S-1 is effective as 2nd line therapy in slowing tumor activity in patients with metastatic pancreatic cancer who have previously received 1st line treatment with a gemcitabine regimen. The study is also looking at the safety of S-1.

Detailed description

Metastatic pancreatic cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1 is a new generation oral fluoropyrimidine that combines Tegafur (5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione \[FT\]), an oral prodrug of 5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine \[CDHP\]), which inhibits 5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium (Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3 compounds is designed to achieve enhanced antitumor activity while decreasing gastrointestinal toxicity.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	S-1	All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial will proceed to the second stage only if sufficient efficacy is demonstrated in Stage 1.

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-06-01
• Completion: 2007-10-01
• First posted: 2008-04-03
• Last updated: 2024-09-03