WithdrawnPhase 2

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

Stopped: 0 participants

0Started 2023-04-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 a…

What they're measuring

Major pathological response rate

Timeframe: 12 weeks

Disease control rate

Timeframe: 6 months

Trial details

NCT IDNCT04481204

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-27