Pancreatic Cancer Study on Adaptive Chemotherapy Before Surgery

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03322995

Provider View

This clinical trial is exploring a flexible treatment approach for patients with pancreatic cancer that can be surgically removed or is borderline removable. The study aims to adjust chemotherapy based on how well the cancer responds to initial treatments.

Patient Parameters

Program Overview

This study is testing a new way to treat pancreatic cancer that can be surgically removed or is close to being removable. The treatment involves standard chemotherapy and radiation, but with a twist: the treatment plan can change based on how the cancer responds. Doctors will use scans, blood tests, and physical assessments to decide if the treatment is working and make adjustments as needed.

Description

In this study, patients with pancreatic cancer will start with standard chemotherapy and radiation treatments. The unique part of this trial is that the treatment plan can be adjusted based on how the cancer responds. Doctors will use CT scans, blood tests for a cancer marker called CA19-9, and physical and mental health assessments to evaluate the treatment's effectiveness.

The cancer's response will be categorized into four groups:

  1. Response: The cancer is shrinking or improving.
  2. Stable Disease: The cancer is not growing but not shrinking either.
  3. Local Disease Progression: The cancer is growing in the original area.
  4. Metastatic Disease Progression: The cancer has spread to other parts of the body.

Based on these evaluations:

  • If the cancer responds well, patients will continue with the same chemotherapy.
  • If the disease is stable, the treatment will switch to a different chemotherapy or a targeted therapy based on the cancer's molecular profile.
  • If the cancer progresses locally, patients will receive radiation therapy.
  • If the cancer spreads, patients will be removed from the trial.

After four months of chemotherapy, patients will receive radiation therapy (50.4 Gray in 28 sessions). If the cancer has not progressed to an inoperable state or spread, surgery will be offered to remove the cancer. Patients who did not complete four months of initial therapy may receive additional treatment after surgery, as decided by their doctors.

Eligibility Criteria

INCLUSION CRITERIA

  • Be 18 years of age or older.

  • Be able to understand and provide written informed consent or have a legally authorized representative (LAR).

  • Have an Eastern Cooperative Group (ECOG) performance status < 2 (please see the appendix).

  • Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment; additional biopsy is not required for the study.

  • Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.

  • Have adequate organ and bone marrow function, as defined by:

    • total leukocytes >3 x10^3/μL.
    • absolute neutrophil count (ANC) >1.5x 10^3/μL.
    • hemoglobin >9 g/dL.
    • platelets >100 x 10^3/μL.
    • creatinine clearance >60 mL/min or creatinine <1.5 mg/dL; bilirubin < 2 mg/dL.
    • aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) <3 x upper limit of normal (ULN). At two weeks from biliary decompression, if the subject's serum AST/ALT remains greater 3x ULN, but has demonstrated a progressive decline, the subject may be enrolled into the trial and appropriate modification and dose adjustments will be made to the assigned regimen. Eligibility of subjects whose AST/ALT remain elevated 3x ULN, without demonstrating a downward trend, will be determined at the discretion of the trial principal investigators.

  • Subjects must be CA19-9 producers as defined by a pretreatment CA 19-9 > 35 U/mL, when total bilirubin <2 mg/dL.

  • Female patients must be postmenopausal (absence of menses for > 1 year), surgically sterile, or have a negative pregnancy test and use at least one form of contraception for four weeks prior to Day 1 of the study, during study treatment and during the first four months after study treatment is discontinued. Male patients must be surgically sterile or use barrier contraception during the study and for four months after the last dose of any study drug.

EXCLUSION CRITERIA

  • Has received more than two months of FOLFIRINOX or mFOLFIRINOX chemotherapy as first-line therapy.
  • No documentation of a CA19-9 value when total bilirubin < 2 prior to initiation of chemotherapy.
  • Has received any additional chemotherapy and/or radiation within three years prior to study enrollment.
  • Has any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in situ carcinoma of the cervix or localized prostate cancer with normal prostate specific antigen) within three years of study enrollment.
  • Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity (BMI >55) or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
  • Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Pregnant or breastfeeding patients or any patient with childbearing potential not using contraception four weeks prior to treatment.

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