The efficacy and the safety of gemcitabine / S-1 combination therapy in patients with advanced non-resectable or post-operative recurrent biliary tract cancer -multicenter phase II study

UMIN ID: UMIN000000590

Registered date:01/02/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-resectable or post-operative recurrent biliary tract cancer
• Date of first enrollment: 2006/12/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Gemcitabine 1,000mg/m2 is administered as a 30-min intravenous infusion on day 1 and day 15. S-1 40mg/m2 is administered orally twice a day from day 1 to day 14 followed by a two-week rest. The cycle is repeated every 4 weeks until evidence of disease progression, patient refusal or unacceptable toxicity.

Outcome(s)

• Primary Outcome: Anti-tumor effect(Response rate, Disease control rate) Safety
• Secondary Outcome: Progression-free survival, Overall survival, Drug administration compliance(Drug intensity, Drug feasibility)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients with an active concomitant infection 2) Patients with digestive ulcer or gastrointestinal bleeding 3) Patients with severe cardiovascular or renal disease 4) Patients with an active pulmonary fibrosis or interstitial pneumonia 5) Patients with uncontrollable massive pleural effusion or massive ascites 6) Patients with an active concomitant malignancy 7) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 8) Patients with a previous history of a severe drug hypersensitivity 9) Patients receiving anti-cancer drugs 10) Inappropriate patients for entry on this study in the judgement of the investigator

Related Information

• Primary Sponsor: Faculty of Medicine, University of Tokyo
• Source(s) of Monetary Support: None