1999
Phase I study of Doxil and vinorelbine in metastatic breast cancer
Burstein HJ, Ramirez MJ, Petros WP, Clarke KD, Warmuth MA, Marcom PK, Matulonis UA, Parker LM, Harris LN, Winer EP. Phase I study of Doxil and vinorelbine in metastatic breast cancer. Annals Of Oncology 1999, 10: 1113-1116. PMID: 10572612, DOI: 10.1023/a:1008323200102.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerM2 days 1Breast cancerDay 1Grade 2 cardiac toxicityPrior anthracycline-based chemotherapyAnthracycline-based chemotherapyPhase II studyFirst treatment cyclePhase I studiesDose escalation schemeFavorable toxicity profilePharmacokinetic studyActive chemotherapeutic agentsHigher doxorubicin concentrationsDoxil administrationVinorelbine administrationSignificant nauseaII studySevere neutropeniaCombination chemotherapyCardiac toxicityCombination therapyEscalation schemeI studies
1995
Oral vinorelbine (Navelbine) in the treatment of advanced breast cancer.
Winer EP, Chu L, Spicer DV. Oral vinorelbine (Navelbine) in the treatment of advanced breast cancer. Seminars In Oncology 1995, 22: 72-8; discussion 78-9. PMID: 7740337.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerOral vinorelbineBreast cancerIntravenous administrationResponse rateMulticenter phase II trialAdvanced breast cancer patientsPhase II trialHigh first-pass effectBreast cancer patientsFirst-pass effectPharmacokinetics of vinorelbineII trialCancer patientsClinical investigationVinorelbineHigh clearance rateSoft gelatin capsulesClearance ratePatientsCancerPharmacokinetic studyLow bioavailabilityAdministrationGelatin capsules
1994
Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors.
Rowinsky EK, Noe DA, Trump DL, Winer EP, Lucas VS, Wargin WA, Hohneker JA, Lubejko B, Sartorius SE, Ettinger DS. Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors. Journal Of Clinical Oncology 1994, 12: 1754-63. PMID: 8083697, DOI: 10.1200/jco.1994.12.9.1754.Peer-Reviewed Original ResearchConceptsMaximum-tolerated doseOral administrationOral formulationOral vinorelbineGrade 3Large first-pass effectLower starting doseSemisynthetic vinca alkaloidChronic oral administrationHepatic blood flowPhase II evaluationPharmacokinetic studyDivided-dose scheduleMaximum plasma concentrationFirst-pass effectSteady-state volumeGelatin capsulesPlasma drug dispositionPharmacologic exposuresPrincipal toxicityStarting doseDose escalationOral dosesOral doseCancer patients