Clinical Trials /

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

NCT04481204

Description:

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.

Related Conditions:
  • Pancreatic Ductal Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: New and Emerging Therapies for the Treatment of Resectable, Borderline Resectable, or Locally Advanced Pancreatic Cancer, PIONEER-Panc Study
  • Official Title: PIONEER-Panc: Phase II Investigations of New and Emerging Therapies for Pancreatic Cancer

Clinical Trial IDs

  • ORG STUDY ID: 2020-0075
  • SECONDARY ID: NCI-2020-04886
  • SECONDARY ID: 2020-0075
  • SECONDARY ID: P30CA016672
  • NCT ID: NCT04481204

Conditions

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

Interventions

DrugSynonymsArms
CisplatinAbiplatin, 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, PlatosinControl arm GroupII(chemotherapy, FOLFIRINOX)
Fluorouracil5 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-2-9757Control arm GroupI(mFOLFIRINOX)
GemcitabinedFdC, dFdCyd, DifluorodeoxycytidineControl arm GroupII(chemotherapy, FOLFIRINOX)
IrinotecanControl arm GroupI(mFOLFIRINOX)
LeucovorinFolinic acidControl arm GroupI(mFOLFIRINOX)
Nab-paclitaxelABI 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 PaclitaxelControl arm GroupII(chemotherapy, FOLFIRINOX)
Oxaliplatin1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669Control arm GroupI(mFOLFIRINOX)

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Control arm GroupI(mFOLFIRINOX)Active ComparatorPatients receive mFOLFIRINOX for 3 months before and after surgery in the absence of disease progression or unacceptable toxicity.
  • Fluorouracil
  • Irinotecan
  • Leucovorin
  • Oxaliplatin
Control arm GroupII(chemotherapy, FOLFIRINOX)Active ComparatorPatients 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.
  • Cisplatin
  • Fluorouracil
  • Gemcitabine
  • Irinotecan
  • Leucovorin
  • Nab-paclitaxel
  • Oxaliplatin
Control arm GroupIII(FOLFIRINOX, radiation therapy)Active ComparatorPatients 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.
  • Fluorouracil
  • Irinotecan
  • Leucovorin
  • Oxaliplatin
Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy)Active ComparatorPatients 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.
  • Cisplatin
  • Fluorouracil
  • Gemcitabine
  • Irinotecan
  • Leucovorin
  • Nab-paclitaxel
  • Oxaliplatin
Control arm GroupV(FOLFIRINOX, radiation therapy)Active ComparatorPatients 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
  • Fluorouracil
  • Irinotecan
  • Leucovorin
  • Oxaliplatin
Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)Active ComparatorPatients 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
  • Cisplatin
  • Fluorouracil
  • Gemcitabine
  • Irinotecan
  • Leucovorin
  • Nab-paclitaxel
  • Oxaliplatin

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Confirmation of clinical stage of
             resectable

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Prior chemotherapy for PDAC is allowed, as
             long as the regimen is considered a standard regimen for PDAC (e.g., gemcitabine,
             gemcitabine-cisplatin, gemcitabine/nab-paclitaxel, gemcitabine/capecitabine,
             FOLFIRINOX). This should be discussed with the study principal investigators (PIs)
             prior to enrollment to ensure the regimen for a given patient is acceptable

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: No current use of immunosuppressive
             medication

          -  PREVIOUSLY TREATED 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

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Life expectancy greater than 6 months

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: ECOG performance status 0 or 1

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Absolute neutrophil count (ANC) >=
             1,500/mm^3

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Platelet count >= 100,000/mm^3

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Creatinine =< 1.5 x upper limit of normal
             (ULN)

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Calc. creatinine clearance > 45 mL/min

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Total bilirubin =< 2.0 mg/dL

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: AST/ALT =< 2.5 x upper limit of normal
             (ULN)

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Hemoglobin >= 8.0 mg/dL

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Pathologically proven
             adenocarcinoma of the pancreas by cytology or biopsy

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Confirmation of clinical stage of
             borderline resectable

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: No prior chemotherapy or radiation
             therapy for PDAC

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: No current use of immunosuppressive
             medication

          -  TREATMENT NAIVE BORDERLINE 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 BORDERLINE RESECTABLE PDAC COHORT: Life expectancy greater than 6
             months

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: ECOG performance status 0 or 1

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Absolute neutrophil count (ANC) >=
             1,500/mm^3

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Platelet count >= 100,000/mm^3

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Creatinine =< 1.5 x upper limit of
             normal (ULN)

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Calc. creatinine clearance > 45
             mL/min

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Total bilirubin =< 2.0 mg/dL

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: AST/ALT =< 2.5 x upper limit of
             normal (ULN)

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Hemoglobin >= 8.0 mg/dL

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Pathologically proven
             adenocarcinoma of the pancreas by cytology or biopsy

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Confirmation of clinical stage
             of borderline resectable

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Prior chemotherapy for PDAC is
             allowed, as long as the regimen is considered a standard regimen for PDAC (e.g.,
             gemcitabine, gemcitabine-cisplatin, gemcitabine/nab-paclitaxel,
             gemcitabine/capecitabine, FOLFIRINOX). This should be discussed with the study PIs
             prior to enrollment to ensure the regimen for a given patient is acceptable

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: No current use of
             immunosuppressive medication

          -  PREVIOUSLY TREATED BORDERLINE 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

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Life expectancy greater than 6
             months

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: ECOG performance status 0 or 1

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Absolute neutrophil count (ANC)
             >= 1,500/mm^3

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Platelet count >= 100,000/mm^3

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Creatinine =< 1.5 x upper limit
             of normal (ULN)

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Calc. creatinine clearance > 45
             mL/min

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Total bilirubin =< 2.0 mg/dL

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: AST/ALT =< 2.5 x upper limit of
             normal (ULN)

          -  PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Hemoglobin >= 8.0 mg/dL

          -  TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Pathologically proven adenocarcinoma of
             the pancreas by cytology or biopsy

          -  TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Confirmation of clinical stage of
             locally advanced

          -  TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: No prior chemotherapy or radiation
             therapy for PDAC

          -  TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Pregnancy and Nursing Status: 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 LOCALLY ADVANCED PDAC COHORT: Life expectancy greater than 6 months

          -  TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: ECOG performance status 0 or 1

          -  TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Absolute neutrophil count (ANC) >=
             1,500/mm^3

          -  TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Platelet count >= 100,000/mm^3

          -  TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Creatinine =< 1.5 x upper limit of
             normal (ULN)

          -  TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Calc. creatinine clearance > 45 mL/min

          -  TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Total bilirubin =< 2.0 mg/dL

          -  TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: AST/ALT =< 2.5 x upper limit of normal
             (ULN)

          -  TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Hemoglobin >= 8.0 mg/dL

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Pathologically proven adenocarcinoma
             of the pancreas by cytology or biopsy

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Confirmation of clinical stage of
             locally advanced

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Prior chemotherapy for PDAC is
             allowed, as long as the regimen is considered a standard regimen for PDAC (e.g.,
             gemcitabine, gemcitabine-cisplatin, gemcitabine/nab-paclitaxel,
             gemcitabine/capecitabine, FOLFIRINOX). This should be discussed with the study PIs
             prior to enrollment to ensure the regimen for a given patient is acceptable

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: No current use of immunosuppressive
             medication

          -  PREVIOUSLY TREATED LOCALLY ADVANCED 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

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Life expectancy greater than 6 months

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: ECOG performance status 0 or 1

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Absolute neutrophil count (ANC) >=
             1,500/mm^3

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Platelet count >= 100,000/mm^3

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Creatinine =< 1.5 x upper limit of
             normal (ULN)

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Calc. creatinine clearance > 45
             mL/min

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Total bilirubin =< 2.0 mg/dL

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: AST/ALT =< 2.5 x upper limit of
             normal (ULN)

          -  PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Hemoglobin >= 8.0 mg/dL

        Exclusion Criteria:

          -  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

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Active malignancy, except basal cell
             carcinoma

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Staging other than resectable PDAC at the
             time of diagnosis

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Receiving any approved or investigational
             anti-neoplastic agent other than the chemotherapies specified in this protocol

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Known uncontrolled (grade >= 2) or active
             gastric or duodenal ulcer disease within 30 days of enrollment

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Prior surgical resection of pancreatic
             tumor

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Known contraindication to iodine-based or
             gadolinium-based IV contrast

          -  PREVIOUSLY TREATED 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)

          -  PREVIOUSLY TREATED 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

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Known active, uncontrolled (high viral
             load) 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

          -  PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Female patients who are pregnant of
             breastfeeding

          -  PREVIOUSLY TREATED 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

          -  PREVIOUSLY TREATED 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

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Previous treatment for PDAC with
             chemotherapy or radiation

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Active malignancy, except basal
             cell carcinoma

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Staging other than borderline
             resectable PDAC

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Known uncontrolled (grade >= 2) or
             active gastric or duodenal ulcer disease within 30 days of enrollment

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Prior surgical resection of
             pancreatic tumor

          -  TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Known contraindication to
             iodine-based or gadolinium-based IV contrast

          -  TREATMENT NAIVE BORDERLINE 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 BORDERLINE RESECTABLE PDAC COHORT: Class III or IV congestive hea
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Major pathological response rate
Time Frame:12 weeks
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Progression free survival
Time Frame: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
Safety Issue:
Description:Will be estimated using the Kaplan-Meier method. Comparisons of these time-to-event endpoints by important covariate subgroups will be made using the log-rank tests. Cox proportional hazards regression models will be explored to evaluate the associations between the time-to-event endpoints and covariates of interest.
Measure:Overall survival
Time Frame:From treatment start till death or last follow-up if the patient is alive, assessed up to 5 years
Safety Issue:
Description:Will be estimated using the Kaplan-Meier method. Comparisons of these time-to-event endpoints by important covariate subgroups will be made using the log-rank tests. Cox proportional hazards regression models will be explored to evaluate the associations between the time-to-event endpoints and covariates of interest.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Last Updated

August 10, 2020