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

• Status: Not yet recruiting
• Trial end date: 2025-04-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Fluorouracil; Gemcitabine; Irinotecan; Leucovorin; Oxaliplatin; Paclitaxel

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