NCT04481204

New and Emerging Therapies for the Treatment of Resectable, Borderline Resectable, or Locally Advanced Pancreatic Cancer, PIONEER-Panc Study

PIONEER-Panc: Phase II Investigations of New and Emerging Therapies for Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study using the Bayesian platform design. There are three clinical stage groups of localized pancreatic cancer: resectable, borderline resectable, and locally advanced disease. Each stage group will have a defined standard of care chemotherapy regimen for a control arm, serving as a basis of comparison. Each group may have one or more experimental arms. Experimental arms may be added to the platform over time, and the effects of the experimental treatments will be tested against the controls for each group.

Detailed description

PRIMARY OBJECTIVES: I. To estimate major pathological response rate. (Resectable and borderline resectable groups \[treatment naive or previously treated\]) II. To estimate 6-month disease control rate. (Locally advanced groups \[treatment naive or previously treated\]) SECONDARY OBJECTIVES: I. To measure progression free survival and overall survival. (Resectable and borderline resectable groups \[treatment naive or previously treated\]) II. To measure progression free survival and overall survival. (Locally advanced groups \[treatment naive or previously treated\]) EXPLORATORY OBJECTIVES: I. To benchmark tissue acquisition protocols for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) analysis in pancreatic ductal adenocarcinoma (PDAC). II. To demonstrate concordance of cell free DNA detected mutations to those detected in the tumor-derived DNA in PDAC. III. To demonstrate response through exosome and circulating tumor DNA. IV. To demonstrate response through the quantification of the immune activation by analyzing T and B cells, peripheral blood mononuclear cells, and tissue biopsies. V. To derive organoids from human PDAC and measure drug response in vitro. VI. To analyze the tumor microenvironment through immunohistochemistry (IHC) and hypoxia staining. VII. To associate prognosis of patients with baseline and follow-up quantitative computed tomography (CT) image based analysis. VIII. To associate clinical and pathological outcomes of patients with changes in radiomic measurements. IX. To correlate quality of life for patients on standard and experimental therapies with laboratory, radiological, pathological, and clinical characteristics. OUTLINE:Patients are assigned to different groups, and each group has a control arm. Within each group, the patient will be randomized to the appropriate control or an experimental arm. The control arms for the groups are: Control arm for Group I (Treatment-naive resectable PDAC): Patients receive fluorouracil, irinotecan, leucovorin, and oxaliplatin (mFOLFIRINOX) for 3 months before and after surgery in the absence of disease progression or unacceptable toxicity. Control arm for Group II (Previously-treated resectable PDAC): Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for up to 4 months in the absence of disease progression or unacceptable toxicity. Control arm for Group III (Treatment-naive borderline resectable PDAC): Patients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors. Control arm for Group IV (Previously-treated borderline resectable PDAC): Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors. Control arm for Group V (Treatment-naive locally advanced PDAC): Patients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors. Control arm for Group VI (Previously-treated locally advanced PDAC): Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors. After completion of study treatment, patients are followed up every 16 weeks.

Conditions

• Borderline Resectable Pancreatic Adenocarcinoma
• Locally Advanced Pancreatic Ductal Adenocarcinoma
• Resectable Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	Given IV
DRUG	Fluorouracil	Given IV
DRUG	Gemcitabine	Given IV
DRUG	Irinotecan	Given IV
DRUG	Leucovorin	Given IV
DRUG	Nab-paclitaxel	Given IV
DRUG	Oxaliplatin	Given IV
RADIATION	Radiation Therapy	Undergo RT

Timeline

• Start date: 2023-04-18
• Primary completion: 2027-04-06
• Completion: 2027-04-06
• First posted: 2020-07-22
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study