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dc.contributor.authorAlbanell, Joan
dc.contributor.authorMontagut, Clara
dc.contributor.authorJones, Eileen T
dc.contributor.authorPronk, Linda
dc.contributor.authorMellado, Begoña
dc.contributor.authorBeech, Janette
dc.contributor.authorGascon, Pere
dc.contributor.authorZugmaier, Gerhard
dc.contributor.authorBrewster, Michael
dc.contributor.authorSaunders, Mark P
dc.contributor.authorValle, Juan W
dc.date.accessioned2009-04-21T16:36:33Z
dc.date.available2009-04-21T16:36:33Z
dc.date.issued2008-05-01
dc.identifier.citationA phase I study of the safety and pharmacokinetics of the combination of pertuzumab (rhuMab 2C4) and capecitabine in patients with advanced solid tumors. 2008, 14 (9):2726-31 Clin. Cancer Res.en
dc.identifier.issn1078-0432
dc.identifier.pmid18451238
dc.identifier.doi10.1158/1078-0432.CCR-07-1980
dc.identifier.urihttp://hdl.handle.net/10541/65697
dc.description.abstractPURPOSE: To study the safety, pharmacokinetics, and recommended dose of the combination of pertuzumab, a humanized monoclonal antibody HER2-dimerization inhibitor, and capecitabine in patients with advanced malignancies. EXPERIMENTAL DESIGN: Patients that had progressed to standard treatment were treated with pertuzumab at a fixed dose of 1,050 mg given i.v. on day 1 plus capecitabine at doses of 825-1,000-1,250 mg/m(2), twice daily orally on days 1 to 14 of each 21-day treatment cycle, in three sequential cohorts. The pharmacokinetics of capecitabine and pertuzumab were studied. Patients received a single dose of capecitabine in a pretreatment phase (day -7) followed by serum sampling for capecitabine and its metabolites. RESULTS: Nineteen patients were accrued and 18 were assessable. The combination of capecitabine and pertuzumab was well tolerated at all dose levels and no dose-limiting toxicities were observed. The most frequent adverse event was asthenia, which was grade 3 in two patients. One asymptomatic pulmonary embolism occurred. No other grade 3 or 4 adverse events or cardiac or left ventricular ejection fraction events were reported. There was no apparent change in the pharmacokinetics of capecitabine and its metabolites when combined with pertuzumab. The pharmacokinetics of pertuzumab was apparently not modified when administered with capecitabine. Disease stabilization was observed in 11 patients. CONCLUSIONS: Pertuzumab and capecitabine were well tolerated at all dose levels. Escalation beyond the highest dose level tested was not planned, as this included the recommended doses of monotherapy for both drugs. In conclusion, this combination is ready for phase II testing.
dc.language.isoenen
dc.subjectCanceren
dc.subjectSolid Tumouren
dc.subjectDrug Treatmenten
dc.subjectDrug Safetyen
dc.subjectClinical Trialen
dc.subject.meshAdolescent
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAntibodies, Monoclonal
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshChild
dc.subject.meshDeoxycytidine
dc.subject.meshFemale
dc.subject.meshFluorouracil
dc.subject.meshHumans
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshNeoplasms
dc.titleA phase I study of the safety and pharmacokinetics of the combination of pertuzumab (rhuMab 2C4) and capecitabine in patients with advanced solid tumors.en
dc.typeArticleen
dc.contributor.departmentMedical Oncology Department, Hospital Clinic, Barcelona, Spain. jalbanell@imas.imim.esen
dc.identifier.journalClinical Cancer Researchen
html.description.abstractPURPOSE: To study the safety, pharmacokinetics, and recommended dose of the combination of pertuzumab, a humanized monoclonal antibody HER2-dimerization inhibitor, and capecitabine in patients with advanced malignancies. EXPERIMENTAL DESIGN: Patients that had progressed to standard treatment were treated with pertuzumab at a fixed dose of 1,050 mg given i.v. on day 1 plus capecitabine at doses of 825-1,000-1,250 mg/m(2), twice daily orally on days 1 to 14 of each 21-day treatment cycle, in three sequential cohorts. The pharmacokinetics of capecitabine and pertuzumab were studied. Patients received a single dose of capecitabine in a pretreatment phase (day -7) followed by serum sampling for capecitabine and its metabolites. RESULTS: Nineteen patients were accrued and 18 were assessable. The combination of capecitabine and pertuzumab was well tolerated at all dose levels and no dose-limiting toxicities were observed. The most frequent adverse event was asthenia, which was grade 3 in two patients. One asymptomatic pulmonary embolism occurred. No other grade 3 or 4 adverse events or cardiac or left ventricular ejection fraction events were reported. There was no apparent change in the pharmacokinetics of capecitabine and its metabolites when combined with pertuzumab. The pharmacokinetics of pertuzumab was apparently not modified when administered with capecitabine. Disease stabilization was observed in 11 patients. CONCLUSIONS: Pertuzumab and capecitabine were well tolerated at all dose levels. Escalation beyond the highest dose level tested was not planned, as this included the recommended doses of monotherapy for both drugs. In conclusion, this combination is ready for phase II testing.


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