locally advanced or metastatic unresectable pancreatic cancer and recurrent pancreatic cancer
Conditions
Interventions
Oral administration of the following dose once-a-day after breakfast on Sunday, Monday, Wednesday, and Friday for 6 weeks. Body surface area (BSA) <
1.25 m2 : 100mg 1.25 m2<
1.5 m2 : 120mg 1.50 m2<
= BSA : 150mg
Oral administration of the following dose once-a-day after breakfast on Sunday, Monday, Wednesday, and Friday for 6 weeks. BSA <
1.25 m2 : 120mg 1.25 m2<
1.5 m2 : 150mg 1.50 m2<
= BSA : 175mg
Oral administration of the following dose once-a-day after breakfast on Sunday, Monday, Wednesday, and Friday for 6 weeks. BSA <
1.25 m2 : 150mg 1.25 m2<
1.5 m2 : 175mg 1.50 m2<
= BSA : 200mg
Sponsors
Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Invasive pancreatic ductal carcinoma histologically confirmed as adenocarcinoma or adenosquamous carcinoma. 2) Locally advanced or metastatic unresectable pancreatic cancer and recurrent pancreatic cancer. Having of measurable lesions must not be required. 3) Patients with no previous treatment (radiotherapy, chemotherapy,immunotherapy, etc.) for pancreatic cancer, except resection. 4) Patients must be >=20 years old and <=80 years old at the time of consent. 5) ECOG Performance Status must be 0 or 1. 6) The following criteria must be satisfied in laboratory tests conducted within 21 days before enrollment. -White blood cell count >=3,500 /mm3 ,<=12,000/mm3 -Neutrophil count >=2,000 /mm3 -Hemoglobin >= 9.0 g/dL -Platelet count >=100,000 /mm3 -Total bilirubin <=2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice) -AST <=150 IU/L -ALT <=150 IU/L -Serum Creatinine <=1.2 mg/dL -Creatinine Clearance >= 60 mL/min 7) Oral intake is possible. 8) Clinically normal ECG within 28 days before registration. 9) Patient must have signed the consent form.
Exclusion criteria
Exclusion criteria: 1) Interstitial pneumonia or pulmonary fibrosis. 2) Watery diarrhea. 3) Severe infections (without viral hepatitis) or being suspected (fever evaluation >=38 degrees). 4) Serious complication (heart failure, renal disorder, liver disorder, bleeding digestive ulcer, intestinal tract paralysis, and etc. ). 5) Moderate or greater pleural effusion, ascites fluid (requiring drainage). 6) Cerebral metastasis. 7) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 3 year) except carcinoma in situ or intramucosal cancer. 8) Patients who require administration of flucytosine, phenytoin, and warfarin. 9) Pregnant females or nursing mothers who can not stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception during the study period. 10) Serious mental disorder. 11) Drug hypersensitivity. 12) Patients who are judged by doctors inappropriate to perform the study safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse event and Dose-Limiting Toxicity(DLT). | — |
Countries
Japan
Contacts
Public ContactMotoki Miyazawa
Wakayama Medical University Second Department of Surgery
Outcome results
None listed