2009
The changing face of Phase 1 cancer clinical trials
Craft BS, Kurzrock R, Lei X, Herbst R, Lippman S, Fu S, Karp DD. The changing face of Phase 1 cancer clinical trials. Cancer 2009, 115: 1592-1597. PMID: 19165808, PMCID: PMC2668727, DOI: 10.1002/cncr.24171.Peer-Reviewed Original ResearchConceptsPhase 2 trialEarly phase clinical trialsPhase 1 studyPhase 1 trialClinical trialsVital sign determinationsCancer clinical trialsPhysical examinationEarly phase cancer clinical trialsWeeks of protocolPhase 2 studyPhase 1 cancer clinical trialsNew drug studyStudy requirementsPhase 1Pharmacokinetic samplingMore patientsMedical oncologyOncology communityLaboratory testsSuch trialsDrug studiesTrialsPhase 1 programElectrocardiogram
2003
Efficacy of Gefitinib, an Inhibitor of the Epidermal Growth Factor Receptor Tyrosine Kinase, in Symptomatic Patients With Non–Small Cell Lung Cancer: A Randomized Trial
Kris MG, Natale RB, Herbst RS, Lynch TJ, Prager D, Belani CP, Schiller JH, Kelly K, Spiridonidis H, Sandler A, Albain KS, Cella D, Wolf MK, Averbuch SD, Ochs JJ, Kay AC. Efficacy of Gefitinib, an Inhibitor of the Epidermal Growth Factor Receptor Tyrosine Kinase, in Symptomatic Patients With Non–Small Cell Lung Cancer: A Randomized Trial. JAMA 2003, 290: 2149-2158. PMID: 14570950, DOI: 10.1001/jama.290.16.2149.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerRadiographic tumor regressionPartial radiographic responseCell lung cancerRadiographic responseTumor regressionEpidermal growth factor receptorOral gefitinibLung cancerOral EGFR tyrosine kinase inhibitorRandomized phase 2 trialEGFR tyrosine kinase inhibitorsAcne-like rashCommunity oncology centersPhase 2 trialLung cancer symptomsPhase 1 trialEfficacy of gefitinibDisease-related symptomsFraction of patientsGrowth factor receptorNSCLC symptomsChemotherapy regimensEpidermal growth factor receptor tyrosine kinaseOverall survival