SWOG Cancer Research Network
This phase III trial compares the effect of adding panitumumab to standard chemotherapy (with nanoliposomal Irinotecan, leucovorin, and 5-fluorouracil \[5-FU\] or irinotecan, leucovorin, and 5-FU or nab-paclitaxel and gemcitabine) versus standard chemotherapy alone in treating patients with KRAS wild type (WT) pancreatic ductal adenocarcinoma that cannot be removed by sugery (unresectable) or that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as nanoliposomal irinotecan, leucovorin, 5-FU, irinotecan, nab-paclitaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal adenocarcinoma.
PRIMARY OBJECTIVE: I. To compare overall survival (OS) between participants with locally advanced or metastatic KRAS wild type (WT) pancreatic ductal adenocarcinoma (PDA) randomized to panitumumab plus second-line cytotoxic chemotherapy (5FU- or gemcitabine-based) versus chemotherapy alone. SECONDARY OBJECTIVES: I. To compare progression-free survival (PFS) between treatment arms. II. To compare the overall response rate (ORR) (ORR, including confirmed and unconfirmed, complete and partial response according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria) between tr…
Inclusion Criteria: * Participants must have a histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas * Participants must have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status determined by tumor tissue-based NGS assay. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or simila…
Undergo blood sample collection
Undergo CT scan
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Ancillary studies