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

Who is this study for? Patients with Pancreatic Adenocarcinoma
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Have a carbohydrate antigen 19-9 (CA19-9) level greater than 35 mg/dL regardless of total bilirubin level.

• Be 18 years of age or older.

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

• 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).

• Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment.

• 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 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.

• 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.

Locations
United States
Arizona
HonorHealth Medical Group
RECRUITING
Scottsdale
Wisconsin
Froedtert & the Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Medical College of Wisconsin Cancer Center Clinical Trials Office
cccto@mcw.edu
866-680-0505
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 87
Treatments
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.
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.
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.
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.
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.
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.
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.
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov