Gemcitabine and S-1 for Advanced Biliary Tract Cancer

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will conduct a phase II study of gemcitabine and S-1 as first-line chemotherapy in patient with advanced biliary tract cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hallym University Medical Center
• Collaborator: Jeil Pharmaceutical Co., Ltd.
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Unresectable, locally advanced, metastatic adenocarcinoma arising from the intra- and extrahepatic biliary ducts or gallbladder

• Initially diagnosed or recurred

• At least one bidimensionally measurable lesion, defined as at least 1x1cm with clearly defined margins on physical examination, on 3-dimentional CT, MRI, or PET-CT

• Age ≥18 and ≤70 years

• Estimated life expectancy ≥3 months

• ECOG performance status ≤2

• Adequate bone marrow function (WBCs ≥4,000/µL or absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL),

• Adequate kidney function (creatinine ≤1.4 mg/dL)

• Adequate liver function (bilirubin ≤1.8 mg/dL, transaminase levels ≤100mg/dL)

• Written informed consent

Exclusion Criteria:

• Other tumor type than adenocarcinoma

• Previous history of chemotherapy (exception : adjuvant chemotherapy)

• Presence of CNS metastasis, psychosis, or seizure

• Obvious bowel obstruction

• Evidence of serious gastrointestinal bleeding

• Past or concurrent history of neoplasm other than biliary adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri

• Pregnant or lactating women, women of childbearing potential not employing adequate contraception

• Other serious illness or medical conditions