2015
Phase 1b study of the mammalian target of rapamycin inhibitor sirolimus in combination with nanoparticle albumin–bound paclitaxel in patients with advanced solid tumors
Abu-Khalaf MM, Baumgart MA, Gettinger SN, Doddamane I, Tuck DP, Hou S, Chen N, Sullivan C, Lezon-Geyda K, Zelterman D, Hatzis C, Deshpande H, Digiovanna MP, Azodi M, Schwartz PE, Harris LN. Phase 1b study of the mammalian target of rapamycin inhibitor sirolimus in combination with nanoparticle albumin–bound paclitaxel in patients with advanced solid tumors. Cancer 2015, 121: 1817-1826. PMID: 25649370, DOI: 10.1002/cncr.29254.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityIntravenous nab-paclitaxelPhase 1b studyAdvanced solid tumorsNab-paclitaxelFDG activityDay 1Solid tumorsNanoparticle albumin-bound paclitaxelMammalian targetWeekly oral doseAcceptable safety profileRapamycin inhibitor sirolimusAlbumin-bound paclitaxelClinical trial endpointsExploratory gene expression analysisPositron emission tomographyStable diseaseTaxane therapyPartial responseWeekly doseComplete responseOral sirolimusPharmacodynamic assessmentOral dose
2011
Phase II Evaluation of Phenoxodiol in Combination With Cisplatin or Paclitaxel in Women With Platinum/Taxane-Refractory/Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
Kelly MG, Mor G, Husband A, O'Malley DM, Baker L, Azodi M, Schwartz PE, Rutherford TJ. Phase II Evaluation of Phenoxodiol in Combination With Cisplatin or Paclitaxel in Women With Platinum/Taxane-Refractory/Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers. International Journal Of Gynecological Cancer 2011, 21: 633-639. PMID: 21412168, DOI: 10.1097/igc.0b013e3182126f05.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialCisplatinDrug Resistance, NeoplasmFallopian Tube NeoplasmsFemaleHumansIsoflavonesMiddle AgedNeoplasms, Glandular and EpithelialOvarian NeoplasmsPaclitaxelPeritoneal NeoplasmsPlatinum CompoundsTaxoidsTreatment FailureTreatment OutcomeConceptsOverall best response rateBetter response rateOvarian cancerStable diseaseRefractory/Partial responseComplete responseDay 1Day 2Response ratePlatinum-resistant ovarian cancerGrade 4 toxicityTreatment-related deathsTreatment-related hospitalizationsPrimary peritoneal cancerPhase II evaluationResistant ovarian cancerCisplatin armEpithelial ovarianPaclitaxel armPaclitaxel weeklyPeritoneal cancerUnacceptable toxicityTreatment armsFallopian tube