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dc.contributor.authorPentheroudakis, Georgeen
dc.contributor.authorBriassoulis, E. Chen
dc.contributor.authorKaravasilis, V.en
dc.contributor.authorMauri, D.en
dc.contributor.authorTzamakou, E.en
dc.contributor.authorRammou, D.en
dc.contributor.authorPavlidis, Nicholasen
dc.creatorPentheroudakis, Georgeen
dc.creatorBriassoulis, E. Chen
dc.creatorKaravasilis, V.en
dc.creatorMauri, D.en
dc.creatorTzamakou, E.en
dc.creatorRammou, D.en
dc.creatorPavlidis, Nicholasen
dc.date.accessioned2018-06-22T09:54:23Z
dc.date.available2018-06-22T09:54:23Z
dc.date.issued2005
dc.identifier.urihttps://gnosis.library.ucy.ac.cy/handle/7/42334
dc.description.abstractPurpose: We performed a phase I study of two fixed dosing schemes of cisplatin, a DNA cross-linker, with intravenous escalating topotecan, a DNA-topoisomerase I inhibitor. Experimental Design: 40 patients with advanced solid tumors received intravenous cisplatin at a fixed dose of either 25 mg/m2 (schedule A) or 20 mg/m2 (schedule B) daily for 3 days with standard hydration. Topotecan escalation proceeded in 0.75, 0.90, 1.0, 1.15 mg/m2 cohorts in schedule A and 1.0,1.1,1.2,1.3 mg/m 2 cohorts in schedule B, administered intravenously at the end of cisplatin infusion daily for 3 days, repeated every 3 weeks. Dose-limiting toxicity (DLT) consisted of protracted grade IV neutropenia, febrile neutropenia, grade IV thrombocytopenia and any grade III/IV non-hematological toxicity. Epoetin and granulocyte colony-stimulating factor support was allowed on severe myeloablation. Endpoints were the identification of maximal tolerated dose (MTD), DLT and other toxicity. Results: The MTD was reached in cohort 25/1.15 mg/m2 in schedule A and 20/1.2 mg/m2 in schedule B. All DLT seen consisted of three episodes of febrile neutropenia and two of grade IV thrombocytopenia in schedule A, with three episodes of febrile neutropenia and one of protracted neutropenia in schedule B. Myelosuppression was substantial in all cohorts despite granulocyte colony-stimulating factor and epoetin support, peaked on the third week of treatment and resulted in administration of chemotherapy at a median of every 4 weeks. Non-hematologic toxicity was mild. The response rate was 51% with seven complete responses occurring in patients with ovarian cancer, small cell and non-small cell lung cancer and cancer of unknown primary. The recommended dose was 20/ 1.1 mg/m 2 for cisplatin and topotecan on schedule B, as the number of responses and administered topotecan dose were higher in schedule B recommended dose with lower cisplatin dose, minimizing problems of nephrotoxicity and vomiting. Conclusions: The schedule B daily cisplatin-topotecan x 3 combination with secondary cytokine support is associated with promising activity and schedule convenience. However, substantial myelosuppression undermines its applicability in the palliative setting, stressing the need for less toxic regimens. Copyright © 2005 S. Karger AG.en
dc.language.isoengen
dc.sourceChemotherapyen
dc.subjectArticleen
dc.subjectCancer chemotherapyen
dc.subjectHumanen
dc.subjectNeoplasmsen
dc.subjectHumansen
dc.subjectAdulten
dc.subjectAgeden
dc.subjectControlled studyen
dc.subjectFemaleen
dc.subjectMiddle ageden
dc.subjectAdvanced canceren
dc.subjectOvary canceren
dc.subjectPriority journalen
dc.subjectAlopeciaen
dc.subjectAnemiaen
dc.subjectAnorexiaen
dc.subjectAntineoplastic combined chemotherapy protocolsen
dc.subjectBone marrow suppressionen
dc.subjectCisplatinen
dc.subjectClinical articleen
dc.subjectClinical trialen
dc.subjectControlled clinical trialen
dc.subjectFatigueen
dc.subjectFebrile neutropeniaen
dc.subjectNeurotoxicityen
dc.subjectNeutropeniaen
dc.subjectThrombocytopeniaen
dc.subjectInfusionsen
dc.subjectIntravenousen
dc.subjectNephrotoxicityen
dc.subjectCardiotoxicityen
dc.subjectDrug administration scheduleen
dc.subjectLung non small cell canceren
dc.subjectLung small cell canceren
dc.subjectDose responseen
dc.subjectDose-response relationshipen
dc.subjectDrugen
dc.subjectSolid tumoren
dc.subjectMaleen
dc.subjectRecombinanten
dc.subjectRecombinant erythropoietinen
dc.subjectVomitingen
dc.subjectCombination chemotherapyen
dc.subjectMaximum tolerated doseen
dc.subjectNauseaen
dc.subjectPhase 1 clinical trialen
dc.subjectCohort analysisen
dc.subjectDehydrationen
dc.subjectAdolescenten
dc.subjectParesthesiaen
dc.subjectGranulocyte colony stimulating factor receptoren
dc.subjectBeta adrenergic receptor blocking agenten
dc.subjectEpoetin alfaen
dc.subjectGranulocyte colony stimulating factoren
dc.subjectHeart supraventricular arrhythmiaen
dc.subjectHematinicsen
dc.subjectHypomagnesemiaen
dc.subjectPhase i trialen
dc.subjectTopotecanen
dc.titlePhase I trial of intravenous cisplatin-topotecan chemotherapy for three consecutive days in patients with advanced solid tumors: Parallel topotecan escalation in two fixed platinum dosing schemesen
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1159/000085624
dc.description.volume51
dc.description.issue2-3
dc.description.startingpage154
dc.description.endingpage161
dc.author.facultyΙατρική Σχολή / Medical School
dc.type.uhtypeArticleen


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