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

NCT04481204 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: 2020-0075NCI-2020-04886
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Borderline Resectable Pancreatic Adenocarcinoma; Resectable Pancreatic Ductal Adenocarcinoma; Locally Advanced Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Major pathological response rate

  Major pathological response is any patient who has grade I or II treatment response. Grade I - 0% residual tumor cells in the specimen (pathologic complete response, grade II - 1 to \< 5% residual tumor cells in the specimen.

  12 weeks

• Disease control rate

  Measured as the proportion of patients without progression.

  6 months

Secondary Outcomes (2)

• Progression free survival

  From the date of treatment initiation to the date of disease progression, recurrence after surgery or death from any cause whichever occurs first, assessed up to 5 years

• Overall survival

  From treatment start till death or last follow-up if the patient is alive, assessed up to 5 years

Study Arms (6)

Control arm GroupI(mFOLFIRINOX)

ACTIVE COMPARATOR

Patients receive mFOLFIRINOX for 3 months before and after surgery in the absence of disease progression or unacceptable toxicity.

Drug: Fluorouracil; Drug: Irinotecan; Drug: Leucovorin; Drug: Oxaliplatin

Control arm GroupII(chemotherapy, FOLFIRINOX)

ACTIVE COMPARATOR

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.

Drug: Cisplatin; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Irinotecan; Drug: Leucovorin; Drug: Nab-paclitaxel; Drug: Oxaliplatin

Control arm GroupIII(FOLFIRINOX, radiation therapy)

ACTIVE COMPARATOR

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.

Drug: Fluorouracil; Drug: Irinotecan; Drug: Leucovorin; Drug: Oxaliplatin; Radiation: Radiation Therapy

Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy)

ACTIVE COMPARATOR

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.

Drug: Cisplatin; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Irinotecan; Drug: Leucovorin; Drug: Nab-paclitaxel; Drug: Oxaliplatin; Radiation: Radiation Therapy

Control arm GroupV(FOLFIRINOX, radiation therapy)

ACTIVE COMPARATOR

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

Drug: Fluorouracil; Drug: Irinotecan; Drug: Leucovorin; Drug: Oxaliplatin; Radiation: Radiation Therapy

Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)

ACTIVE COMPARATOR

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

Drug: Cisplatin; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Irinotecan; Drug: Leucovorin; Drug: Nab-paclitaxel; Drug: Oxaliplatin; Radiation: Radiation Therapy

Interventions

Cisplatin DRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone''s Chloride, Peyrone''s Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Control arm GroupII(chemotherapy, FOLFIRINOX); Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy); Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)

Fluorouracil DRUG

Given IV

Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Control arm GroupI(mFOLFIRINOX); Control arm GroupII(chemotherapy, FOLFIRINOX); Control arm GroupIII(FOLFIRINOX, radiation therapy); Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy); Control arm GroupV(FOLFIRINOX, radiation therapy); Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)

Gemcitabine DRUG

Given IV

Also known as: dFdC, dFdCyd, Difluorodeoxycytidine

Control arm GroupII(chemotherapy, FOLFIRINOX); Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy); Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)

Irinotecan DRUG

Given IV

Control arm GroupI(mFOLFIRINOX); Control arm GroupII(chemotherapy, FOLFIRINOX); Control arm GroupIII(FOLFIRINOX, radiation therapy); Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy); Control arm GroupV(FOLFIRINOX, radiation therapy); Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)

Nab-paclitaxel DRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel

Control arm GroupII(chemotherapy, FOLFIRINOX); Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy); Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)

Leucovorin DRUG

Given IV

Also known as: Folinic acid

Control arm GroupI(mFOLFIRINOX); Control arm GroupII(chemotherapy, FOLFIRINOX); Control arm GroupIII(FOLFIRINOX, radiation therapy); Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy); Control arm GroupV(FOLFIRINOX, radiation therapy); Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)

Oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669

Control arm GroupI(mFOLFIRINOX); Control arm GroupII(chemotherapy, FOLFIRINOX); Control arm GroupIII(FOLFIRINOX, radiation therapy); Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy); Control arm GroupV(FOLFIRINOX, radiation therapy); Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)

Radiation Therapy RADIATION

Undergo RT

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Control arm GroupIII(FOLFIRINOX, radiation therapy); Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy); Control arm GroupV(FOLFIRINOX, radiation therapy); Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)

Eligibility Criteria

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

You may qualify if:

• TREATMENT NAIVE RESECTABLE PDAC COHORT: Pathologically proven adenocarcinoma of the pancreas by cytology or biopsy
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Confirmation of clinical stage of resectable
• TREATMENT NAIVE RESECTABLE PDAC COHORT: No prior chemotherapy or radiation therapy for PDAC
• TREATMENT NAIVE RESECTABLE PDAC COHORT: No current use of immunosuppressive medication
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Not pregnant and not nursing, for women of childbearing potential, a negative urine or blood pregnancy test done =\< 7 days prior to registration is required
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Life expectancy greater than 6 months
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Absolute neutrophil count (ANC) \>= 1,500/mm\^3
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Platelet count \>= 100,000/mm\^3
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Creatinine =\< 1.5 x upper limit of normal (ULN)
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Calculated (Calc.) creatinine clearance \> 45 mL/min
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Total bilirubin =\< 2.0 mg/dL
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Hemoglobin \>= 8.0 mg/dL
• PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Pathologically proven adenocarcinoma of the pancreas by cytology or biopsy

You may not qualify if:

• TREATMENT NAIVE RESECTABLE PDAC COHORT: Previous treatment for PDAC with chemotherapy or radiation
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Active malignancy, except basal cell carcinoma
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Staging other than resectable PDAC
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Known uncontrolled (grade \>=2) or active gastric or duodenal ulcer disease within 30 days of enrollment
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Prior surgical resection of pancreatic tumor
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Known contraindication to iodine-based or gadolinium-based intravenous (IV) contrast
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second or third degree atrioventricular heart block without a permanent pacemaker in place)
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Class III or IV congestive heart failure as defined by the New York Heart Association functional classification system \< 6 months prior to screening
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Known active, uncontrolled (high viral load) human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
• Patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Female patients who are pregnant of breastfeeding
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \< 1% per year when used consistently and correctly
• TREATMENT NAIVE RESECTABLE PDAC COHORT: Have significant psychiatric, social, or medical condition(s) that could increase the subject's risk, interfere with protocol adherence, or affect the subject's ability to give informed consent
• PREVIOUSLY TREATED RESECTABLE PDAC COHORT: The patient is treatment naive
• PREVIOUSLY TREATED RESECTABLE PDAC COHORT: The patient previously received radiation to the abdomen for any reason

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: lead

Related Publications (1)

• Douglas JE, Liu S, Ma J, Wolff RA, Pant S, Maitra A, Tamm EP, Bhosale P, Katz MHG, Varadhachary GR, Koay EJ. PIONEER-Panc: a platform trial for phase II randomized investigations of new and emerging therapies for localized pancreatic cancer. BMC Cancer. 2022 Jan 3;22(1):14. doi: 10.1186/s12885-021-09095-7.

  PMID: 34980020 DERIVED

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Fluorouracil; dehydroftorafur; Gemcitabine; Irinotecan; Leucovorin; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes; Oxaliplatin; Radiotherapy; Radiation

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations; Coordination Complexes; Therapeutics; Physical Phenomena

Study Officials

• Eugene J Koay

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 22, 2020
• Study Start: April 18, 2023
• Primary Completion: April 27, 2026
• Study Completion: April 27, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)