NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT04539808
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Pancreatic Adenocarcinoma
  • Stage 0 Pancreatic Cancer American Joint Committee on Cancer v8
  • Stage I Pancreatic Cancer American Joint Committee on Cancer v8
  • Stage III Pancreatic Cancer American Joint Committee on Cancer v8
  • Stage IV Pancreatic Cancer American Joint Committee on Cancer v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    Given PO
  • Fluorouracil — DRUG
    Given IV
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Losartan Potassium — DRUG
    Given PO
  • Oxaliplatin — DRUG
    Given IV
  • Radiation Therapy — RADIATION
    Undergo short-course or long-course RT
  • Resection — PROCEDURE
    Undergo surgical resection
  • Diagnostic Imaging — PROCEDURE
    Undergo diagnostic imaging
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Gemcitabine — DRUG
    Given IV
  • Nab paclitaxel — DRUG
    Given IV

Study Details

This phase II trial evaluates whether early switching from modified fluorouracil/irinotecan/leucovorin/oxaliplatin (mFOLFIRINOX) chemotherapy regimen to a combination of gemcitabine and nab-paclitaxel (GA) before surgery is effective in treating patients with pancreatic cancer that can be surgically removed (resectable or borderline resectable), or that has spread to nearby tissue or lymph nodes and cannot be removed by surgery (locally-advanced unresectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, oxaliplatin, gemcitabine, and nab-paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The study will also evaluate the drug losartan in combination with mFOLFIRINOX or GA.

Key Dates

Start date
May 27, 2021
Status verified
Dec 2025
Primary completion
Dec 8, 2024
Completion
Jan 5, 2027

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (mFOLFIRINOX, chemotherapy)
    mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months. GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles. LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT. RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT

Primary Outcome Measure

Proportion of Resectable or BRPC Participants With R0 Resection [ Time Frame: Up to time of surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239-

Find similar trials in Portland, OR

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
OHSU Knight Cancer Institute· Portland, OR

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