2018
A phase IB/II randomized study of mFOLFIRINOX (mFFOX) + pegylated recombinant human hyaluronidase (PEGPH20) versus mFFOX alone in patients with good performance status metastatic pancreatic adenocarcinoma (mPC): SWOG S1313 (NCT #01959139).
Ramanathan R, McDonough S, Philip P, Hingorani S, Lacy J, Kortmansky J, Thumar J, Chiorean E, Shields A, Behl D, Mehan P, Gaur R, Seery T, Guthrie K, Hochster H. A phase IB/II randomized study of mFOLFIRINOX (mFFOX) + pegylated recombinant human hyaluronidase (PEGPH20) versus mFFOX alone in patients with good performance status metastatic pancreatic adenocarcinoma (mPC): SWOG S1313 (NCT #01959139). Journal Of Clinical Oncology 2018, 36: 208-208. DOI: 10.1200/jco.2018.36.4_suppl.208.Peer-Reviewed Original ResearchMetastatic pancreatic adenocarcinomaPhase II studyOverall survivalII studyPhase Ib/IIProphylactic growth factor supportUntreated metastatic pancreatic adenocarcinomaRandomized phase II studyGemcitabine/nab-paclitaxelAdequate organ functionMedian overall survivalGrowth factor supportInterim futility analysisRecombinant human hyaluronidaseClinical trial informationDelivery of gemcitabineBolus 5FULMWH prophylaxisMedian OSTumor hyaluronanCombination armNab-paclitaxelPrimary endpointThromboembolic eventsStandard arm
2015
Final analysis of a phase II study of Yale-modified FOLFIRINOX (mFOLFIRINOX) in metastatic pancreatic cancer (MPC).
James E, Cong X, Yao X, Hahn C, Kaley K, Li J, Kortmansky J, Fischbach N, Cha C, Salem R, Stein S, Hochster H, Lacy J. Final analysis of a phase II study of Yale-modified FOLFIRINOX (mFOLFIRINOX) in metastatic pancreatic cancer (MPC). Journal Of Clinical Oncology 2015, 33: 395-395. DOI: 10.1200/jco.2015.33.3_suppl.395.Peer-Reviewed Original ResearchMetastatic pancreatic cancerResponse rateProphylactic pegfilgrastimEntire cohortPhase II open-label studyFinal analysisECOG PS 0ECOG PS 0/1Grade 3/4 toxicitiesOpen-label studyPhase II studyBolus 5FUPS 0/1Febrile neutropeniaLAPC patientsPeritoneal diseaseII studyPS 0Surgical resectionUnacceptable toxicityImproved tolerabilityPeripheral neuropathyMetastatic sitesPancreatic cancerFOLFIRINOX