Status:
COMPLETED
Liposomal Irinotecan, S-1, and Oxaliplatin in Advanced Pancreatic Adenocarcinoma
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Hallym University Medical Center
Conditions:
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
In present study, the investigators evaluate the safety and efficacy of OIS-derived NASOX regimen (nal-IRI, S-1, oxaliplatin) in advanced pancreatic cancer. NASOX regimen contains nal-IRI, which has r...
Detailed Description
Pancreatic adenocarcinoma is the seventh leading cause of cancer-related mortality worldwide, and it carries dismal prognosis with a 5-year survival rate of 1-2%. The pivotal ACCORD11 trial, FOLFIRINO...
Eligibility Criteria
Inclusion
- Age 19 years and older
- Histologically or cytologically confirmed, measurable pancreatic adenocarcinoma
- Treatment naïve locally advanced or metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow function as defined by platelets ≥ 100 x 109/L , neutrophils ≥ 1.5 x 109/L and hemoglobin \> 9 g/dL; transfusion is allowed, provided interval is ≥ 7 days prior to screening
- Adequate renal function, with serum creatinine \< 1.5 x upper limit of normal (ULN). And calculated clearance ≥ 50 mL/min/1.73m2 for patients with serum creatinine levels above or below the institutional normal value. Actual body weight should be used for calculating creatinine clearance using the Cockcroft-Gault Equation (CreatClear = Sex x ((140 - Age) / (SerumCreat)) x (Weight / 72); for patients with body mass index (BMI) \>30 kg/m2, lean body weight should be used instead
- Adequate hepatic function with serum total bilirubin ≤ 2 x ULN (biliary drainage is allowed for biliary obstruction), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN is acceptable if liver metastases are present)
- History of any second malignancy in the last 3 years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 3 years.
- Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrolment and agree to use effective barrier contraception during the period of therapy and for one month after the last dose.
- Written, informed consent to the study
Exclusion
- Endocrine or acinar pancreatic carcinoma
- Uncontrolled CNS metastases (Note: Patients who require steroids should be on a stable or decreasing dose to be eligible)
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance
- Obstruction of gastrointestinal tract
- Active gastrointestinal bleeding
- Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol
- Active infection or an unexplained fever \> 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled), which in the investigator's opinion might compromise the patient's participation in the trial or affect the study outcome
- Use of strong CYP3A4 inhibitors or inducers, or strong UGT1A1 inhibitors (patients are ineligible if unable to discontinue the use of strong CYP3A4 or UGT1A1 inhibitors at least 1 week or strong CYP3A4 inducers at least 2 weeks prior to receiving first dose of irinotecan liposome injection),
- presence of any contraindications for irinotecan, nal-IRI, S1 and Oxaliplatin
- Female patients who are pregnant (positive pregnancy test at screening) or breast-feeding
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04662112
Start Date
June 15 2021
End Date
December 30 2024
Last Update
January 28 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hallym University Medical Center
Anyang-si, Gyeonggi-do, South Korea, 05505
2
Asan Medical Center
Seoul, South Korea, 05505