Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial

NCT03322995 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PRO00030656
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Keywords

Neoadjuvant; pancreatic adenocarcinoma; pancreas cancer; pancreatic cancer; molecular profiling; CA19-9; surgery; MCW

Outcome Measures

Primary Outcomes (1)

• Completion of all intended neoadjuvant therapy and surgical therapy

  This measure is the number of subjects completing all intended neoadjuvant therapy and surgical therapy.

  Five years.

Secondary Outcomes (2)

• Overall survival

  Five years

• Progression-free survival

  Five years

Study Arms (3)

Restaging: Response to Treatment

EXPERIMENTAL

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: First-line Chemotherapy

Restaging: Patients with Stable Disease

EXPERIMENTAL

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: Second-line Chemotherapy

Restaging: Local Disease Progression

EXPERIMENTAL

After the first restaging evaluation, further treatment will be based on treatment response. If, at the initial restaging, 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

Interventions

First-line Chemotherapy DRUG

The first-line therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) or best available standard of care.

Also known as: Fluorouracil, Folinic acid, Camptosar, Eloxatin

Restaging: Response to Treatment

Second-line Chemotherapy DRUG

Second line therapies will be multi-agent and contain gemcitabine. Molecular profiling data from the initial endoscopic ultrasound (EUS)/ fine needle aspirate (FNA) biopsy may be used at the discretion of the treating physician.

Also known as: Gemzar

Restaging: Patients with Stable Disease

Chemoradiation RADIATION

50.4 Gy in 28 fractions.

Restaging: Local Disease Progression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fluorouracil; Leucovorin; Irinotecan; Oxaliplatin; Gemcitabine; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Kathleen Christians, MD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Clinical Cancer Center

CONTACT

414-805-8900; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 26, 2017
• Study Start: June 21, 2018
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2032
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)