Patients with unresectable advanced pancreatic cancer (Stage IV, TNM Classification) who were primarily resistant to gemcitabine monotherapy
Conditions
Interventions
Arm 1: S-1 monotherapy Patients who enrolled this study will receive either arm of the therapy 3 weeks after their prior treatment has finished. In the S-1 arm, S-1 is given orally for four weeks, f
1.25 to 1.5 m2, 100 mg and BSA over1.5 m2, 120 mg. This course is repeated until progressive disease or severe toxicities are confirmed.
Arm 2: S-1/Gem Patients who enrolled this study will receiv
1.25 to 1.5 m2, 80 mg and BSA over1.5 m2, 100 mg. This course is repeated until progressive disease or severe toxicities are confirmed.
Sponsors
Keio University School of Medicine, Department of Medicine, Division of Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible criteria in this study are as follows: 1)Cases with clinically proven carcinoma of the pancreas 2) Stage IV (TMN classification, UICC) unresectable patients. 3) Ages between 20 to 80 years old 4) An Eastern Cooperative Oncology Group performance status of 0 or 1. (Karnofsky performance status (KPS) of 70%) 5) Patients with solid tumor(s) which can be evaluated by Response Evaluation Criteria in Solid Tumours (RECIST) guidelines 6) Patients who previously had received gemcitabine monotherapy as the first-line chemotherapy and had been diagnosed as Progressive Disease (PD) 7) patients who experienced grade 4 hematologic toxicity are ineligible. 8) Patients must not have received any chemotherapy or radiotherapy for 3 weeks before entering this study 9) prior dose of the gemcitabine in the past chemotherapy>= 800 mg/m(2) 10) patients who are capable of oral intake. 11) Sufficient organ function within 1-week from the enrollment: leukocytes >= 3,500 /mm3 and <= 12,000 /mm3, neutriphils >= 2,000 /mm3, platelets >= 100,000 /mm3, hemoglobin >= 9.0 g/dL, serum total bilirubin <= 2 times from upper normal value of the facility, serum aspartate aminotransferase (AST) <= 2.5 times from upper normal value of the facility, serum alanine aminotransferase (ALT) <= 2.5 times from upper normal value of the facility, creatinin clearance>=60 mL/mil 12) Written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria are as follows: 1) Prior history of radiation therapy to pancreatic cancer 2) Presence of other active malignancy 3) Presence of severe complications such as plumonary fibrosis, interstitial pneumonia, intestinal paralysis, uncontrolled diabetes, uncontrolled hypertension, myocardial infarction within six months, unstable angina, severe infection, renal failure, liver failure, , etc 4) Past history of allergic reaction to gemcitabine 5) Regular use of frucitocin, fenitoin or warfarin 6) Past history of radiation therapy to the lung(s). 7) Massive ascites or pleural effusion 8) Severe diarrhea 9) active intestinal bleeding 10) Pregnancy, breast feeding, or women who desire to preserve fecundity or men who desire to have children 11) Severe mental disorder 12) regular use of steroids 13) Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, overall survival, adverse event, QOL | — |
Countries
Japan
Contacts
Public ContactMasayuki Adachi, MD
Keio University School of Medicine, Department of Medicine Gastroenterology
Outcome results
None listed