NeoOPTIMIZE: Early Switching of Chemotherapy Before Surgery for Treating Pancreatic Cancer

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04539808

Provider View

This study is testing if switching chemotherapy treatments early can help treat pancreatic cancer that can be removed by surgery or has spread nearby but can't be removed. It also looks at using the drug losartan with these treatments.

Patient Parameters

Program Overview

This phase II study is exploring whether changing from one chemotherapy treatment (mFOLFIRINOX) to another (gemcitabine and nab-paclitaxel) before surgery can effectively treat pancreatic cancer that is either removable by surgery or has spread to nearby areas but can't be removed. The study also examines the use of the drug losartan with these chemotherapy treatments. Chemotherapy works by stopping cancer cells from growing, dividing, or spreading.

Description

The main goal of this study is to see if the treatment can lead to successful surgery without cancer cells at the edges of the removed tissue in patients with pancreatic cancer that can be surgically removed. Other goals include measuring how long patients live without the cancer growing or returning, and overall survival rates. The study will also look at the safety of the treatment and any surgical complications.

Participants will start with the mFOLFIRINOX chemotherapy regimen, which includes several drugs given through an IV. If the cancer progresses or there are side effects, they may switch to the GA regimen, which includes gemcitabine and nab-paclitaxel. Losartan, a drug taken by mouth, will also be given to some patients.

If the cancer is not involving major blood vessels after chemotherapy, patients may have surgery. If there is still some involvement, radiation therapy may be given before surgery. Throughout the study, patients will have regular imaging tests and blood samples taken to monitor their progress.

After completing the study treatment, patients will be followed up regularly to check their health and any signs of cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Confirmed diagnosis of pancreatic ductal carcinoma.
  • No evidence of cancer spread to distant organs.
  • Must be fit for planned surgery.
  • No previous chemotherapy for pancreatic cancer, except possibly one month of standard treatment.
  • Adequate blood counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men must agree to use contraception.
  • Participants on certain blood pressure medications may continue them instead of losartan.

Exclusion Criteria

  • Previous extensive chemotherapy or radiation for pancreatic cancer.
  • Cancer spread to distant organs.
  • Other active cancers or recent history of cancer with less than a 90% cure rate.
  • Medical conditions that make surgery too risky.
  • Certain heart conditions unless well-controlled.
  • Recent major surgery.
  • Use of other cancer treatments not allowed in the study.
  • Allergies to study drugs.
  • Pregnant or breastfeeding women.
  • Conditions that could interfere with the study or increase risk of side effects.

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