A Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, and 5-Fluorouracil/Leucovorin versus Nab-Paclitaxel plus Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Cancer

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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 (WIRB)

Purpose

The purpose of this study is to assess the safety and effectiveness of irinotecan liposome injection when given together with the standard cancer drugs 5-fluorouracil/leucovorin (5-FU/LV) and oxaliplatin in patients who have not been previously treated for metastatic pancreatic cancer. This therapy will be compared to standard treatment with nab-paclitaxel plus gemcitabine. Patients will be randomly assigned to one treatment combination or the other.

Irinotecan liposome injection is already approved in combination with 5-FU/LV for the treatment of pancreatic cancer after failure of initial therapy with gemcitabine. Its use in this study, in previously untreated patients, is considered investigational.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic pancreatic cancer and may not have received treatment for advanced disease.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Alice Zervoudakis at 914-367-7368.

Protocol

20-362

Phase

III

Investigator

Co-Investigators