Patients with gemcitabine-refractory metastatic pancreatic cancer
Conditions
Interventions
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:do
=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.
Sponsors
National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed 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 2 weeks between last chemotherapy treatment and start of present chemotherapy regimen 8) Adequate organ function a. WBC : 3,500/mm3 b. neutrophils : 1,500/mm3 c. platelets : 100,000/mm3 d. Hb : 9.0 g/dL e. T-Bil : 2.0 mg/dL f. GOT, GPT : 100 U/L g. Cr : 1.1 mg/dL 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 |
|---|---|
| Phase 1: Rate of dose-limiting toxicity Phase 2: Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, Progression free survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactChigusa Morizane
National Cancer Center Hospital Hepatobiliary and Pancreatic Oncology Division
Outcome results
None listed