unresected/recurrent metastatic pancreatic cancer
Conditions
Interventions
Gemcitabine 1000 mg/m2 IV one time over 30 minutes. Weekly dosing on Days 1, 8, and 15 of 28 day cycles. If severe toxicity occurs, a dose should be reduced. nab-paclitaxel 125 mg/m2 IV one tim
Sponsors
Shimane University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histopathologically confirmed pancreatic cancer(adenocarcinoma and adenosquamous carcinoma) (2) unresected/recurrent metastatic pancreatic cancer (3) Have measurable lesions by RECIST ver1.1 (4) No prior systemic chemotherapy, immunotherapy or radiotherapy ( Adjuvant chemotherapy was allowed) (5) ECOG performance status of 0, 1 or 2 (6) 20<= years old, <80 years old. (7) Expected survival period is more than 3 months (8) The organ function must be kept within 14 days before registration 8-1 leukocyte >= 3,000/mcL 8-2 neutrophil >=1,500/mcL 8-3 platelet >=75,000/mcL 8-4 hemoglobin >=10.0 g/dL. 8-5 T-Bilirubin >=2.0 mg/dL 8-6 AST =<100 IU/L (AST =<300 IU/L with liver metastasis) 8-7 ALT =<100 IU/L (ALT =<300 IU/L with liver metastasis) 8-8 serum creatinine =<1.5 mg/dL (9) written informed consent got from the patient
Exclusion criteria
Exclusion criteria: (1) Active concomitant malignancy or history of another malignancy within the last 5years (2) Symptomatic brain metastasis (3) Severe infectious diseases (4) Subjects with the past history of Interstitial pneumonia or pulmonary fibrosis (5) Subjects with the past history of severe heart disease (6) Severe Paresthesia or Sensory disorder with motor dysfunction (7) Severe pleural effusion, ascites, or pericardial effusion (8) Subjects with the past history of severe diseases (kidney disease,liver disease, heart disease). (9) History of Radiation therapy for pancrearic cancer (10) Symptomatic brain metastases or Clinically suspected brain metastases. (11) Men/Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test (12) Inappropriate to be enrolled in this study judged by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Tolerability of MK615 within 8 weeks Phase II: Response rate | — |
Countries
Japan
Contacts
Public ContactIchiro Moriyama
Shimane University Hospital Oncology/Hematology
Outcome results
None listed