1981
Animal toxicology for early clinical trials with anticancer agents.
Rozencweig M, Von Hoff D, Staquet M, Schein P, Penta J, Goldin A, Muggia F, Freireich E, DeVita V. Animal toxicology for early clinical trials with anticancer agents. American Journal Of Clinical Oncology 1981, 4: 21-8. PMID: 6783332.Peer-Reviewed Original ResearchConceptsPhase I clinical trialEarly clinical trialsClinical trialsOrgan system toxicityStarting doseSystem toxicityChemotherapeutic agentsDose-escalation stepsCommon toxic effectsGastrointestinal intoleranceInitial doseClinical dataEscalation stepsAnimal findingsToxic doseToxic manifestationsIndividual drugsPredictive valueAnimal toxicologyMiceDoseIdentical scheduleLD10Acceptable dosesDogs
1978
High volume intraperitoneal chemotherapy (“Belly bath”) for ovarian cancer
Jones R, Myers C, Guarino A, Dedrick R, Hubbard S, DeVita V. High volume intraperitoneal chemotherapy (“Belly bath”) for ovarian cancer. Cancer Chemotherapy And Pharmacology 1978, 1: 161-166. PMID: 373916, DOI: 10.1007/bf00253116.Peer-Reviewed Original ResearchConceptsOvarian cancerIntraperitoneal chemotherapyPhase I clinical trialAdvanced stage diseaseIntraperitoneal fluid volumeIntraperitoneal methotrexateComplete remissionTreatment modalitiesPharmacologic principlesClinical trialsPeritoneal cavityTherapeutic effectivenessChemotherapyPharmacokinetic modelingDialysis fluidToxicologic studiesCancerFluid volumeDrug distributionRational chemotherapyFurther investigationRemissionPatientsMethotrexatePharmacokinetics