A randomized, placebo-controlled, double-blind phase 2 study of docetaxel compared to docetaxel plus zosuquidar (LY335979) in women with metastatic or locally recurrent breast cancer who have received one prior chemotherapy regimen

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dc.contributor.authorRuff P.
dc.contributor.authorVorobiof D.A.
dc.contributor.authorJordaan J.P.
dc.contributor.authorDemetriou G.S.
dc.contributor.authorMoodley S.D.
dc.contributor.authorNosworthy A.L.
dc.contributor.authorWerner I.D.
dc.contributor.authorRaats J.
dc.contributor.authorBurgess L.J.
dc.date.accessioned2011-05-15T16:15:52Z
dc.date.available2011-05-15T16:15:52Z
dc.date.issued2009
dc.description.abstractPurpose: To determine if concomitant administration of docetaxel plus zosuquidar.3HC1 can prolong progression-free survival in patients with metastatic breast cancer. Methods: A randomized, double-blind, multicenter, placebo-controlled clinical trial comparing docetaxel plus 500 mg zosuquidar.3HCl (DZ) with docetaxel plus placebo (DP). Results: A total of 170 patients were enrolled and randomly assigned to treatment. The median age was 53 years (range, 31-74 years). 81.7% of patients had prior chemotherapy in the adjuvant setting and 18.3% in the neoadjuvant setting. The median progression-free survival time was statistically different between groups [7.2 months (DZ) vs. 8.3 months (DP)]. Once the stratification factor relative to progression following prior chemotherapy was considered, no significant treatment difference existed. Conclusion: The combination of zosuquidar.3HCl plus docetaxel is safe. The analysis of efficacy data is complex, but it can be concluded that there is no difference in progression-free survival, overall survival, or response rate in the study as a whole. © 2009 Springer-Verlag.
dc.description.versionArticle
dc.identifier.citationCancer Chemotherapy and Pharmacology
dc.identifier.citation64
dc.identifier.citation4
dc.identifier.issn03445704
dc.identifier.other10.1007/s00280-009-0925-9
dc.identifier.urihttp://hdl.handle.net/10019.1/13522
dc.subjectdocetaxel
dc.subjectplacebo
dc.subjectzosuquidar
dc.subjectadjuvant chemotherapy
dc.subjectadult
dc.subjectaged
dc.subjectalanine aminotransferase blood level
dc.subjectanaphylaxis
dc.subjectanemia
dc.subjectarticle
dc.subjectaspartate aminotransferase blood level
dc.subjectbreast cancer
dc.subjectcancer chemotherapy
dc.subjectcancer combination chemotherapy
dc.subjectcancer growth
dc.subjectcancer survival
dc.subjectclinical trial
dc.subjectcombination chemotherapy
dc.subjectcomparative study
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdizziness
dc.subjectdouble blind procedure
dc.subjectdrug efficacy
dc.subjectdrug formulation
dc.subjectdrug hypersensitivity
dc.subjectdrug safety
dc.subjectdrug storage
dc.subjectdrug withdrawal
dc.subjectedema
dc.subjectfatigue
dc.subjectfebrile neutropenia
dc.subjectfemale
dc.subjectgamma glutamyl transferase blood level
dc.subjecthuman
dc.subjecthyperglycemia
dc.subjecthypokalemia
dc.subjecthyponatremia
dc.subjectleukopenia
dc.subjectlymphocytopenia
dc.subjectmajor clinical study
dc.subjectmetastasis
dc.subjectmonotherapy
dc.subjectmulticenter study
dc.subjectmultiple cycle treatment
dc.subjectneutropenia
dc.subjectoverall survival
dc.subjectparesthesia
dc.subjectperipheral edema
dc.subjectperipheral neuropathy
dc.subjectphase 2 clinical trial
dc.subjectpriority journal
dc.subjectprogression free survival
dc.subjectrandomized controlled trial
dc.subjectrecurrent cancer
dc.subjectsensory neuropathy
dc.subjectside effect
dc.subjectskin exfoliation
dc.subjectthrombocytopenia
dc.subjecttreatment failure
dc.subjecttreatment response
dc.subjectAdult
dc.subjectAged
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectBreast Neoplasms
dc.subjectDibenzocycloheptenes
dc.subjectDisease-Free Survival
dc.subjectDouble-Blind Method
dc.subjectFemale
dc.subjectHumans
dc.subjectMiddle Aged
dc.subjectNeoplasm Metastasis
dc.subjectPlacebos
dc.subjectQuinolines
dc.subjectRecurrence
dc.subjectTaxoids
dc.titleA randomized, placebo-controlled, double-blind phase 2 study of docetaxel compared to docetaxel plus zosuquidar (LY335979) in women with metastatic or locally recurrent breast cancer who have received one prior chemotherapy regimen
dc.typeArticle
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