An open-label, randomised, multicentre, phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/leucovorin versus nab-paclitaxel plus gemcitabine in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas

Purpose

The primary objective of this study is to evaluate the efficacy of the regimen of irinotecan liposome injection + oxaliplatin + 5-fluorouracil (5-FU)/leucovorin (LV) versus nab-paclitaxel + gemcitabine in improving overall survival (OS) in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas.

Criteria

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 tumors measurable by CT scan (or MRI, if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria.

You Cannot:

Received prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy:

Palliative radiotherapy is permitted

Received 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.

Have only localised advanced disease.

Have known history of central nervous system (CNS) metastases

Have clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, diarrhea > Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, or partial bowel obstruction.

History of any second malignancy in the last 2 years

Any concurrent illnesses that would be a relative contraindication to trial participation such as active cardiac or liver disease

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, subjects with tumor fever may be enrolled), which in the investigator’s opinion might compromise the subject’s participation in the study or affect the study outcome.

Major surgery, other than diagnostic surgery, within 4 weeks prior to randomization.

Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1. Subjects are ineligible if:

they are unable to discontinue the use of strong inhibitors of CYP3A, CYP2C8 and UGT1A1 at least 1 week prior to randomisation

they are unable to discontinue the use of strong CYP3A and CYP2C8 inducers at least 2 weeks prior to randomisation.

Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.

History of connective tissue disorders (e.g. lupus, scleroderma, arteritis nodosa).

History of interstitial lung disease, history of slowly progressive dyspnoea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.

History of peripheral artery disease (e.g. claudication, Leo Buerger's disease).

Details

Arm 1:          Days 1 and 15 of each 28-day cycle

Irinotecan liposome injection at 50 mg/m2(FBE) over 90 min

Oxaliplatin at 60 mg/m2 over 120 minutes

LV (l+d racemic form-generic form) 400 mg/m2 over 30 minutes)

5-FU will be administered 2400 mg/m2 over 46-hours

Arm 2:          Days 1, 8 and 15 of each 28-day cycle:

Nab-paclitaxel administered at 125 mg/m2 over 35 minutes (±5 minutes)

Gemcitabine administered at 1000 mg/m2 over 30 minutes (±5 minutes)



Interested in more information on clinical research? Contact WK Physician Network Clinical Research at318-212-8613

Interested in more information? Contact Us:

Anil Veluvolu, M.D., Principal Investigator
Hematology- oncology Associates
(318) 212-8620

IRB: Western
IRB Number:
Trial Type: NA
Sponsor: Ipsen