A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment

Overview

About this study

The purpose of this study is to look at the effectiveness and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting.
  • Initial diagnosis of metastatic disease must have occurred ≤ 6 weeks prior to screening.
  • Subject has one or more metastatic tumours measurable by computed tomography (CT) scan (or magnetic resonance imaging (MRI), if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subject has adequate biological parameters as demonstrated by the following blood counts:
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3 without the use of hemopoietic growth factors within the last 7 days prior to randomisation;
    • Platelet count ≥100,000/^;
    • Haemoglobin (Hgb) ≥ 9 g/dL obtained ≤ 14 days prior to randomisation.
  • Adequate hepatic function as evidenced by:
    • Serum total bilirubin ≤ 1.5 x ULN (biliary drainage is allowed for biliary obstruction); and
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN is acceptable if liver metastases are present).
  • Adequate renal function as evidenced by creatinine clearance ≥ 30 mL/min.
  • Adequate coagulation studies (obtained ≤ 14 days prior to randomisation) as demonstrated by prothrombin time and partial thromboplastin time within normal limits (≤ 1.5 x ULN ).

Exclusion Criteria:

  • Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy.
  • Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present.
  • Subject has only localised advanced disease.
  • Documented serum albumin < 3 g/dL.
  • Known history of central nervous system (CNS) metastases.
  • Clinically significant gastrointestinal disorder.
  • History of any second malignancy in the last 2 years.
  • Concurrent illnesses that would be a relative contraindication to trial participation.
  • Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.
  • Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ryan Carr, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions