None listed
Conditions
Interventions
Drug : Modified FOLFIRINGS Arm
D1 Oxaliplatin 65 mgm2 IV over 90 mins
D1 Irinotecan 135 mgm2 IV over 90 mins
D1 Leucovorin 400 mgm2 IV over 2 hrs (= Levofolic acid 200 mgm2 IV over 2 hrs)
D1-2 5 - FU1
Sponsors
Gyeongsang National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adenocarcinoma of a pancreas that has been diagnosed histologically 2) Metastatic pancreatic cancer 3) In the case of a failure in the first-line chemotherapy, including gemcitabine, or a recurrence within six months after the adjuvant chemotherapy with gemcitabine 4) Age: Not more than 19 years old and not more than 70 years old 5) ECOG performance status of = 1 6) A person who has identified adequate bone marrow, liver, kidney and heart function • Number of Absolute Neutrophiles (ANC) = 1.5 x 109 / L • Number of thrombocytes = 100 x 109 / L • Total bilirubin = 1.5 x upper limit of normal ( < 3.0 x ULN , in case of conducting of drainage procedure and expecting the normalization of the level ) • AST and/or ALT = 3 x upper limit of normal • Creatinine = 1.5 mg dL or creatinine clearance = 50 ml / min 7) The person who signed the informed consent
Exclusion criteria
Exclusion criteria: 1) Previously treated with irinotecan or oxaliplatin 2) Patients who receive fluoropyrimidine-based therapy including 5-FU within 6 months 3) Patients with central nervous system metastasis that are not controlled by steroids or radiation therapy 4) Allergic reaction for study drug 5) A person who has a history of malignancy except non-melanoma skin cancer, well-differentiated thyroid cancer, and cervical carcinoma in situ within five years 6) A person who cannot follow protocols such as non-cooperative or unable to follow-up 7) A person who is pregnant or breast-feeding 8) A person with grade 2 or more peripheral neuropathy with functional disability before registering to this study 9) Active infection or serious illness requiring systemic therapy 10) Contraindication to study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment response rate;Safety and tolerability;Progression-free survival;Quality of life | — |
Countries
Korea, Republic of
Contacts
Public ContactJeong Kang
Gyeongsang National University Hospital
Outcome results
None listed