2005
A Phase I Clinical Trial of the Sequential Combination of Irinotecan Followed by Flavopiridol
Shah MA, Kortmansky J, Motwani M, Drobnjak M, Gonen M, Yi S, Weyerbacher A, Cordon-Cardo C, Lefkowitz R, Brenner B, O'Reilly E, Saltz L, Tong W, Kelsen DP, Schwartz GK. A Phase I Clinical Trial of the Sequential Combination of Irinotecan Followed by Flavopiridol. Clinical Cancer Research 2005, 11: 3836-3845. PMID: 15897584, DOI: 10.1158/1078-0432.ccr-04-2651.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBilirubinCamptothecinCell Cycle ProteinsCyclin-Dependent Kinase Inhibitor p21Drug Administration ScheduleDrug InteractionsFemaleFlavonoidsHumansIntracellular Signaling Peptides and ProteinsIrinotecanMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPiperidinesTreatment OutcomeTumor Suppressor Protein p53ConceptsCombination therapyCycle 1 dose-limiting toxicitiesPhase I clinical trialDose-limiting diarrheaPhase II dosePosttreatment tumor biopsiesSignificant pharmacokinetic interactionsAdvanced solid tumorsDose-limiting toxicityPhase I trialBaseline serum bilirubinColorectal cancer xenograftsWild-type p53 tumorsMumol/LBaseline bilirubinFlavopiridol concentrationsStable diseasePartial responseI trialPharmacokinetic interactionsSerum bilirubinDifferentiation-related gene-1Responsive diseaseHepatocellular cancerCancer xenografts
2003
Phase I clinical study of infusional 5-fluorouracil with oxaliplatin and gemcitabine (FOG regimen) in patients with solid tumors
Goel S, Bulgaru A, Hochster H, Wadler S, Zamboni W, Egorin M, Ivy P, Leibes L, Muggia F, Lockwood G, Harvey E, Renshaw G, Mani S. Phase I clinical study of infusional 5-fluorouracil with oxaliplatin and gemcitabine (FOG regimen) in patients with solid tumors. Annals Of Oncology 2003, 14: 1682-1687. PMID: 14581279, DOI: 10.1093/annonc/mdg453.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityAdvanced solid tumorsSolid tumorsCycle 1Day 1Cycle 1 dose-limiting toxicitiesDose levelsPhase I clinical studyGrade 3 toxicityPhase II doseGemcitabine combinationNovel regimenPartial responseClinical studiesPatientsGemcitabineOxaliplatinRPTDTitration schemeTumorsDL-4RegimenCycle 2Further investigationDose
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