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PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples (PANCREAS)

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ClinicalTrials.gov Identifier: NCT04683315
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Susan Tsai, Medical College of Wisconsin

Study Description
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Brief Summary:
This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: mFOLFIRINOX Treatment Regimen Drug: Gemcitabine/Nab-paclitaxel Treatment Regimen Radiation: Chemoradiation Phase 2

Detailed Description:
The study intervention involves molecular profiling Purity Independent Subtyping of Tumors (PurIST) subtyping of pretreatment Endoscopic Ultrasound Fine Needle Aspiration (EUS/FNA) samples to determine pancreatic cancer subtype. Neoadjuvant therapy is directed based on the molecular subtype (classical vs. basal). Patients with classical subtype will receive a standard chemotherapy (mFOLFIRINOX) and patients with basal subtype will receive an alternative standard therapy (gemcitabine/nab-paclitaxel).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Subtype diagnosis and classification: Basal
Patients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer. Upon diagnosis, patients categorized as basal will receive two months of the Gemcitabine/Nab-paclitaxel Treatment Regimen.
 Drug: Gemcitabine/Nab-paclitaxel Treatment Regimen
This regimen will be nab-paclitaxel and gemcitabine.
Other Names:
  • Gemzar
  • Abraxane
Experimental: Subtype diagnosis and classification: Classical
Patients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer. Patients in the classical group will receive two months of the mFOLFIRINOX Treatment Regimen.
 Drug: mFOLFIRINOX Treatment Regimen
This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
Other Names:
  • Fluorouracil
  • Folinic acid
  • Camptosar
  • Eloxatin
Experimental: Basal Group: Restaging: Response to Treatment
After the first restaging evaluation, further treatment will be based on treatment response. Patients who demonstrate a response [decline in carbohydrate antigen 19-9 (CA19-9) values] and radiographic response, along with preserved performance status) will be maintained on the first line chemotherapy for an additional two months.
 Drug: Gemcitabine/Nab-paclitaxel Treatment Regimen
This regimen will be nab-paclitaxel and gemcitabine.
Other Names:
  • Gemzar
  • Abraxane
Experimental: Classical Group: Restaging: Response to Treatment
After the first restaging evaluation, further treatment will be based on treatment response. Patients who demonstrate a response [decline in carbohydrate antigen 19-9 (CA19-9) values] and radiographic response, along with preserved performance status) will be maintained on the first line chemotherapy for an additional two months.
 Drug: mFOLFIRINOX Treatment Regimen
This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
Other Names:
  • Fluorouracil
  • Folinic acid
  • Camptosar
  • Eloxatin
Experimental: Basal Group: Restaging: Patients with Stable Disease
Patients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months.
 Drug: mFOLFIRINOX Treatment Regimen
This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
Other Names:
  • Fluorouracil
  • Folinic acid
  • Camptosar
  • Eloxatin
Experimental: Classical Group: Restaging: Patients with Stable Disease
Patients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months.
 Drug: Gemcitabine/Nab-paclitaxel Treatment Regimen
This regimen will be nab-paclitaxel and gemcitabine.
Other Names:
  • Gemzar
  • Abraxane
Experimental: Basal Group: Restaging: Local Disease Progression
Further treatment will be based on treatment response. If the patient has local disease progression amenable to surgical resection, he or she will receive chemoradiation, rather than continued chemotherapy, so the window of opportunity for surgical resection is not lost.
 Radiation: Chemoradiation
50.4 Gy in 28 fractions.
Experimental: Classical Group: Restaging: Local Disease Progression
Further treatment will be based on treatment response. If the patient has local disease progression amenable to surgical resection, he or she will receive chemoradiation, rather than continued chemotherapy, so the window of opportunity for surgical resection is not lost.
 Radiation: Chemoradiation
50.4 Gy in 28 fractions.


Outcome Measures
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Primary Outcome Measures :
  1. Subjects who receive PurIST classification-directed therapy. [ Time Frame: 12 weeks ]
    The number of subjects who receive PurIST classification-directed therapy and have a treatment response following 12 weeks of therapy.


Secondary Outcome Measures :
  1. Treatment response for subjects with basal subtype tumors. [ Time Frame: 12 weeks ]
    The number of patients with basal subtype tumors who have a treatment response.

  2. Treatment response for subjects with classical subtype tumors. [ Time Frame: 12 weeks ]
    The number of patients with classical subtype tumors who have a treatment response.

  3. Subjects with basal subtype tumors who complete all intended neoadjuvant therapy and surgical therapy. [ Time Frame: One year ]
    The number of subjects completing all intended neoadjuvant therapy and surgical therapy.

  4. Subjects with classical subtype tumors who complete all intended neoadjuvant therapy and surgical therapy. [ Time Frame: One year ]
    The number of subjects completing all intended neoadjuvant therapy and surgical therapy.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (for Screening)

  1. Have suspicion of pancreas adenocarcinoma and plan for endoscopic biopsy. Agrees to additional EUS biopsy to be performed at the first-restaging timepoint and tissue collection from surgical specimen.
  2. Have a carbohydrate antigen 19-9 (CA19-9) level greater than 35 mg/dL regardless of total bilirubin level.

Inclusion Criteria (for Treatment)

  1. Be 18 years of age or older.
  2. Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
  3. Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment Have an Eastern Cooperative Group (ECOG) performance status < 2 (please see the appendix).
  4. Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment.
  5. Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.

  6. Have adequate organ and bone marrow function, as defined by

    • total leukocytes >3 x103/μL.
    • absolute neutrophil count (ANC) >1.5x 103/μL.
    • hemoglobin >9 g/dL.
    • platelets >100 x 10e3/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 PIs.
  7. Subjects must be CA19-9 producers as defined by a pretreatment CA 19-9 > 35 U/mL, when total bilirubin <2 mg/dL
  8. 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:

  1. Has received chemotherapy and/or radiation within three years prior to study enrollment.
  2. 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.
  3. 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.
  4. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  5. Pregnant or breastfeeding patients or any patient with childbearing potential not using contraception four weeks prior to treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683315


Contacts
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Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office 866-680-0505 ext 8900 cccto@mcw.edu

Locations
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United States, Arizona
HonorHealth Medical Group Recruiting
Scottsdale, Arizona, United States, 85258-4566
Contact: Erkut Borazanci, MD    480-323-1350    eborazanci@honorhealth.com   
Contact: Gayle Jameson, APNP    480-323-1350      
United States, Wisconsin
Froedtert & the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Susan Tsai, MD    414-955-1400    stsai@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Susan Tsai, MD Medical College of Wisconsin
More Information
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Responsible Party: Susan Tsai, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04683315    
Other Study ID Numbers: PRO00039451
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Susan Tsai, Medical College of Wisconsin:
molecular profiling
neoadjuvant
pancreatic adenocarcinoma
pancreas cancer
 CA19-9
surgery
MCW
Additional relevant MeSH terms:
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Gemcitabine
Paclitaxel
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
 Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs