2015
Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors.
Wang D, Braiteh F, Lee J, Denlinger C, Shepard D, Chaudhary A, Lin Y, Gao L, Asakiewicz C, Nasroulah F, LoRusso P. Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors. Journal Of Clinical Oncology 2015, 33: 691-691. DOI: 10.1200/jco.2015.33.3_suppl.691.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAdvanced malignant solid tumorsPharmacokinetics of irinotecanMalignant solid tumorsMetabolite SN-38Folinic acidSN-38Safety populationStandard therapyEastern Cooperative Oncology Group performance statusSolid tumorsCycle 1Maximum observed drug concentrationFatigue/astheniaPhase II studyKey eligibility criteriaDose-normalized areaNew safety concernsC maxII studyPerformance statusAdverse eventsStudy treatmentIntravenous infusionPlasma concentrations
2012
A phase I study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced, HER2-positive (HER2+) breast cancer.
Munster P, Miller K, Krop I, Dhindsa N, Reynolds J, Geretti E, Niyikiza C, Nielsen U, Hendriks B, Wickham T, Moyo V, LoRusso P. A phase I study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced, HER2-positive (HER2+) breast cancer. Journal Of Clinical Oncology 2012, 30: tps663-tps663. DOI: 10.1200/jco.2012.30.15_suppl.tps663.Peer-Reviewed Original ResearchAdvanced breast cancerMaximum feasible doseBreast cancerMM-302Liposomal doxorubicinHER2-positive breast cancerTumor cellsAdequate performance statusAnthracycline-free regimensBone marrow reserveDose-escalation portionClinical benefit rateDose-limiting toxicityDose-escalation designHER2-positive cancersPreliminary efficacy dataHuman phase IStandard therapy existsBreast cancer therapyAvailable anthracyclinesPrimary endpointSecondary endpointsMarrow reservePerformance statusStandard therapy
2007
Phase I experience with c-MET inhibitor XL880 administered orally to patients (pts) with solid tumors
Eder J, Heath E, Appleman L, Shapiro G, Wang D, Malburg L, Zhu A, Leader T, Wolanski A, LoRusso P. Phase I experience with c-MET inhibitor XL880 administered orally to patients (pts) with solid tumors. Journal Of Clinical Oncology 2007, 25: 3526-3526. DOI: 10.1200/jco.2007.25.18_suppl.3526.Peer-Reviewed Original ResearchStable diseaseTumor biopsiesPhase ITreatment tumor biopsiesCommon adverse eventsECOG performance statusPhase II trialPhase 1 studyCorrelative studiesHepatocyte growth factor receptorInhibition of PDGFRβAdequate liverEvaluable ptsGrowth factor receptorII trialRECIST criteriaAdverse eventsBrain metastasesHepatic transaminasesPartial responsePerformance statusRenal functionDaily dosePlasma markersNeck cancerPhase I trial of intravenous 17-allylaminogeldanamycin (A) and oral sorafenib (B) in pretreated advanced malignancy: Plasma Hsp90α induction correlates with clinical benefit
Vaishampayan U, Sausville E, Horiba M, Quinn M, Heilbrun L, Burger A, Ivy P, Li J, Lorusso P. Phase I trial of intravenous 17-allylaminogeldanamycin (A) and oral sorafenib (B) in pretreated advanced malignancy: Plasma Hsp90α induction correlates with clinical benefit. Journal Of Clinical Oncology 2007, 25: 3531-3531. DOI: 10.1200/jco.2007.25.18_suppl.3531.Peer-Reviewed Original ResearchAdvanced malignanciesClinical benefitGrade 3 hand-foot syndromeAdequate organ functionGrade 2 nauseaGrade 3 fatigueResponse-evaluable patientsHand-foot syndromePhase II dosePhase I trialSystemic cancer therapyDose cohortsEvaluable patientsInevaluable patientsNCI-CTEPOral sorafenibStable diseaseB. PatientsClinical responseFoot syndromeLatter patientsMajor toxicityPartial responsePerformance statusStable patients
1989
Low-Dose Continuous Infusion 5-Fluorouracil and Cisplatin
LoRusso P, Pazdur R, Redman B, Kinzie J, Vaitkevicius V. Low-Dose Continuous Infusion 5-Fluorouracil and Cisplatin. American Journal Of Clinical Oncology 1989, 12: 486-490. PMID: 2686394, DOI: 10.1097/00000421-198912000-00005.Peer-Reviewed Original ResearchConceptsContinuous infusionLow-dose continuous infusionMedian performance statusHand-foot syndromeSubclavian vein thrombosisDose continuous infusionMeasurable diseaseMedian durationMedian survivalPartial responsePerformance statusVein thrombosisComplete responseMedian ageGastric ulcerationPatientsSingle agentAntineoplastic activityCisplatinMonthsRest periodInfusionTrialsSurvivalToxicity