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
2016
LAPACT: An open-label, multicenter phase II trial of nab -paclitaxel ( nab -P) plus gemcitabine (Gem) in patients (pts) with locally advanced pancreatic cancer (LAPC).
Philip P, Lacy J, Dowden S, Sastre J, Bathini V, Cardin D, Ma W, Sobrero A, Koski S, Borg C, Tonini G, Rivera F, Hwang J, Knoble J, Al Baghdadi T, Saif W, Meiri E, Kayitalire L, Li J, Hammel P. LAPACT: An open-label, multicenter phase II trial of nab -paclitaxel ( nab -P) plus gemcitabine (Gem) in patients (pts) with locally advanced pancreatic cancer (LAPC). Journal Of Clinical Oncology 2016, 34: tps477-tps477. DOI: 10.1200/jco.2016.34.4_suppl.tps477.Peer-Reviewed Original ResearchCycles of nabDisease control rateProgressive diseaseOverall survivalEastern Cooperative Oncology Group performance statusMulticenter phase II trialPhase III MPACT trialAdequate organ functionAdvanced pancreatic cancerCycles of therapySafety of nabEffective systemic therapyImproved local controlPhase II trialProgression-free survivalLonger overall survivalOverall response rateQuality of lifeMedian TTFMPACT trialSignificant ascitesUnresectable LAPCExploratory endpointsPrimary endpointSecondary endpoints