Phase I/II study on combination therapy consisting of a fixed dose-rate infusion of gemcitabine with oral fluorinated pyrimidine compound S-1 (FGS) in patients with gemcitabine-refractory advanced pancreatic cancer

UMIN ID: C000000450

Registered date:20/07/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with gemcitabine-refractory metastatic pancreatic cancer
• Date of first enrollment: 2006/06/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Gemcitabine,Day1 Level 0:600 mg/m2/60 min Level 1:800 mg/m2/80 min Level 2:1000 mg/m2/100 min Level 3:1200 mg/m2/120 min Level 4:1200 mg/m2/120 min S-1, Days 1 - 7 Level 0:dose A Level 1:dose A Level 2:dose A Level 3:dose A Level 4:dose B BSA / daily dose A / daily dose B <=1.25 m2 / 80 mg / 100 mg 1.25 m2 - 1.5 m2 / 100 mg / 120 mg >1.5 m2 / 120 mg / 150 mg Repeat every 2 weeks.

Outcome(s)

• Primary Outcome: Phase 1: Rate of dose-limiting toxicity Phase 2: Response rate
• Secondary Outcome: Toxicity, Progression free survival, Overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Regular use of fenitoin, warfarin or frucitocin 2) History of fluorinated pyrimidine use 3) Severe diarrhea 4) Severe mental disorder 5) Severe infection 6) Severe complication 7) Intestinal pneumonia or lung fibrosis 8) History of chest radiotherapy 9) Massive pleural or abdominal effusion 10) Symptomatic brain metastasis 11) History of other active malignancy 12) Pregnancy or the desire to preserve fecundity 13) Inadequate physical condition, as diagnosed by primary physician

Related Information

• Primary Sponsor: National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare