Metastatic pancreatic cancer patients with a family history of pancreatic/breast/ovarian/prostate cancer or with a personal history of breast/ovarian/prostate cancer.
Conditions
Interventions
Gemcitabine plus oxaliplatin combination therapy: Gemcitabine (1,000mg/m2, div, over 100 minutes, day1), Oxaliplatin (100mg/m2, div, over 120 minutes, day1), every 2 weeks
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as pancreatic cancer with histologically or cytologically proven adenocarcinoma 2) Metastatic pancreatic cancer 3) Aged 20 to 79 years old 4) ECOG Performance Status of 0, 1 or 2 5) Patient who meet at least one of the following: a) Patient who has one or more first-degree relatives with pancreatic, breast, ovarian and/or prostate cancer (Gleason score >=7). b) Patient who has two or more close blood relatives (first- , second-, and third-degree relatives) with pancreatic, breast, ovarian and/or prostate cancer (Gleason score >=7) on same side of family. c) Personal history of breast, ovarian and/or prostate cancer (Gleason score >=7) 6) Patients who are determined that FOLFIRINOX therapy and gemcitabine plus nab-paclitaxel therapy are not suitable by the attending physician. However on receiving a explanation of FOLFIRINOX therapy and GEM + nab-paclitaxel therapy, patients who wish to participate in the current study could be enrolled. 7) Previously untreated with systemic chemotherapy for pancreatic cancer other than neoadjuvant or adjuvant chemotherapy ended more than 6 months before 8) Meets the following criteria within 7days before enrollment a) White blood cell count =< 12,000/mm3 b) Absolute neutrophil count >= 1,000/mm3, c) Hemoglobin >= 9.0 g/dL d) Platelet count >= 100,000/mm3 e) Total bilirubin =< 2.0 mg/dl; however, =< 3.0mg/dl in a subject who is treated with biliary drainage f) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 100 IU/l; however, =< 150 IU/l in a subject who has liver metastases g) Serum creatinine =< 1.2 mg/dl or caclculated creatinine clearance (by the Cockcroft-Gault formula) >= 60 ml/minutes. 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 3 years) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy 2) Known metastasis to the central nervus system 3) Presence of uncontrollable moderate or severe ascites and/or pleural effusion 4) Grade 2 or more of peripheral sensory neuropathy or peripheral motor neuropathy 5) Oral intake is impossible 6) Major surgery within 4 weeks 7) Blood transfusion or G-CSF within 2 weeks 8) Patients requiring systemic steroids medication 9) Unstable angina pectoris within 3 weeks, or with a history of myocardial infarction within 6 months 10) Interstitial pneumonia, pulmonary fibrosis 11) Severe complications such as heart failure, renal failure, liver failure, peptic ulcer with active bleeding, intestinal paralysis, uncontrolled diabetes mellitus, etc 12) Active infection requiring systemic therapy 13) Pregnant or lactating women or women of childbearing potential, Male expecting partner's pregnancy 14) Psychosis or severe mental disorder 15) History of sever allergic reaction to gemcitabine or oxaliplatin 16) Impossible to use both iodine and gadolinium due to being allergic to contrast agent 17) Inadequate physical condition, as diagnosed by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression-free survival, response rate, adverse events | — |
Countries
Japan
Contacts
Public ContactHideaki Takahashi
National Cancer Center Hospital East Department of Hepatobiliary and Pancreatic Oncology
Outcome results
None listed