Patients with gemcitabine-refractory advanced biliary tract cancer
Conditions
Interventions
S-1 was administered until disease progression. Dose of S-1: 80mg/m2 for 28 days, followed by a rest period of 14 days. BSA / daily dose <
=1.25 m2 / 80 mg 1.25 m2 - 1.5 m2 / 100 mg >
1.5 m2 / 120 mg
Sponsors
National Cancer Center Hospital East Hepatobiliary and Pancreatic Oncology Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Biliary tract cancer histologically confirmed as adenocarcinoma 2) Progression during GEM-based first-line chemotherapy 3) Oral intake is possible 4) Measurable or assessable metastatic lesion(s) 5) Age of more than 20 years 6) ECOG performance status (PS) of 0 to 2 7) Interval of at least 3 weeks between last chemotherapy treatment and start of present chemotherapy regimen 8) Adequate organ function 9) Written informed consent
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, progression free survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactEiichiro Suzuki
National Cancer Center Hospital East Hepatobiliary and Pancreatic Oncology Division
Outcome results
None listed