Phase II trial of ZD0473 as second-line therapy in mesothelioma

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dc.contributor.authorGiaccone G.
dc.contributor.authorO'Brien M.E.R.
dc.contributor.authorByrne M.J.
dc.contributor.authorBard M.
dc.contributor.authorKaukel E.
dc.contributor.authorSmit B.
dc.date.accessioned2011-05-15T16:16:18Z
dc.date.available2011-05-15T16:16:18Z
dc.date.issued2002
dc.description.abstractA phase II, open-label, non-comparative, multicentre trial of the platinum analogue ZD0473 as second-line therapy for pleural mesothelioma has been completed. The objectives were to evaluate the activity and tolerability of ZD0473 in patients with relapsed or progressive disease who had received one prior chemotherapy regimen. Forty-seven patients were recruited onto the trial, all aged >18 years with a life-expectancy >12 weeks, and World Health Organization (WHO) performance status ≤2. A starting dose of 120 mg/m 2 was administered to 14 patients, six of whom subsequently had their dose escalated to 150 mg/m2. Thirty-three patients received a starting dose of 150 mg/m2. In total, 147 treatment cycles were administered (median number of cycles 3 [range 1-6]). The main toxicity of ZD0473 was haematological (thrombocytopenia) and the most common non-haematological adverse event was nausea. There was no clinically significant nephro-, neuro-, or oto-toxicity. Of the 43 patients evaluable for response, 12% had a minor response (defined by a reduction in lesion size ≥10% but <50%), 44% had stable disease, 40% had disease progression, and two patients died before an objective response could be assigned. Median time to progression and death in evaluable patients was 77 days (95% confidence interval [CI]: 44, 105 days) and 203 days (95% CI: 165, 277 days), respectively. In conclusion, although ZD0473 demonstrated a manageable tolerability profile, no complete or partial responses were seen in second-line treatment of mesothelioma. This trial also demonstrates that clinical trials in second-line mesothelioma patients are feasible. © 2002 Elsevier Science Ltd. All rights reserved.
dc.description.versionArticle
dc.identifier.citationEuropean Journal of Cancer
dc.identifier.citation38
dc.identifier.citationSUPPL. 8
dc.identifier.issn09598049
dc.identifier.urihttp://hdl.handle.net/10019.1/13721
dc.subjectalkaloid
dc.subjectamminedichloro(2 methylpyridine)platinum
dc.subjectantiemetic agent
dc.subjectcisplatin
dc.subjectdoxorubicin
dc.subjectgemcitabine
dc.subjectifosfamide
dc.subjectmethotrexate
dc.subjectmitomycin C
dc.subjectnavelbine
dc.subjectplatinum derivative
dc.subjectvinblastine
dc.subjectamminedichloro(2 methylpyridine)platinum(II)
dc.subjectamminedichloro(2-methylpyridine)platinum(II)
dc.subjectantineoplastic agent
dc.subjectplatinum complex
dc.subjectadult
dc.subjectaged
dc.subjectanemia
dc.subjectanorexia
dc.subjectarticle
dc.subjectcancer growth
dc.subjectcancer relapse
dc.subjectchemotherapy
dc.subjectclinical article
dc.subjectclinical protocol
dc.subjectclinical trial
dc.subjectconstipation
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdeath
dc.subjectdose response
dc.subjectdrug activity
dc.subjectdrug efficacy
dc.subjectdrug tolerability
dc.subjectdyspnea
dc.subjectfemale
dc.subjecthuman
dc.subjectleukopenia
dc.subjectlife expectancy
dc.subjectmalaise
dc.subjectmale
dc.subjectmulticenter study
dc.subjectnausea
dc.subjectnephrotoxicity
dc.subjectneurotoxicity
dc.subjectneutropenia
dc.subjectopen study
dc.subjectototoxicity
dc.subjectpain
dc.subjectphase 2 clinical trial
dc.subjectpleura mesothelioma
dc.subjectpriority journal
dc.subjectthorax pain
dc.subjectthrombocytopenia
dc.subjectvomiting
dc.subjectworld health organization
dc.subjectchemically induced disorder
dc.subjecthematologic disease
dc.subjectintravenous drug administration
dc.subjectmesothelioma
dc.subjectmiddle aged
dc.subjectpleura tumor
dc.subjecttreatment outcome
dc.subjectAdult
dc.subjectAged
dc.subjectAntineoplastic Agents
dc.subjectDose-Response Relationship, Drug
dc.subjectDyspnea
dc.subjectFemale
dc.subjectHematologic Diseases
dc.subjectHumans
dc.subjectInfusions, Intravenous
dc.subjectMale
dc.subjectMesothelioma
dc.subjectMiddle Aged
dc.subjectOrganoplatinum Compounds
dc.subjectPleural Neoplasms
dc.subjectTreatment Outcome
dc.titlePhase II trial of ZD0473 as second-line therapy in mesothelioma
dc.typeArticle
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