Phase II study of SPI-77 (sterically stabilised liposomal cisplatin) in advanced non-small-cell lung cancer.

2.50
Hdl Handle:
http://hdl.handle.net/10541/72867
Title:
Phase II study of SPI-77 (sterically stabilised liposomal cisplatin) in advanced non-small-cell lung cancer.
Authors:
White, Shane C; Lorigan, Paul C ( 0000-0002-8875-2164 ) ; Margison, Geoffrey P; Margison, Jennifer M; Martin, F; Thatcher, Nick; Anderson, Heather; Ranson, Malcolm R
Abstract:
To determine the efficacy and tolerability of SPI-77 (sterically stabilised liposomal cisplatin) at three dose levels in patients with advanced non-small-cell lung cancer (NSCLC). Patients had Stage IIIB or IV NSCLC and were chemo-naïve, and Eastern Oncology Cooperative Group 0-2. The first cohort received SPI-77 at 100 mg m-2, the second 200 mg m-2 and the final cohort 260 mg m-2. Patients had also pharmacokinetics and analysis of leucocyte platinum (Pt)-DNA adducts performed. Twenty-six patients were treated, with 22 patients being evaluable for response. Only one response occurred at the 200 mg m-2 dose level for an overall response rate of 4.5% (7.1% at >or=200 mg m-2). No significant toxicity was noted including nephrotoxicity or ototoxicity aside from two patients with Grade 3 nausea. No routine antiemetics or hydration was used. The pharmacokinetic profile of SPI-77 was typical for a liposomally formulated drug, and the AUC appeared to be proportional to the dose of SPI-77. Plasma Pt levels and leucocyte DNA adduct levels did not appear to rise with successive doses. SPI-77 demonstrates only modest activity in patients with NSCLC.
Affiliation:
Christie Hospital NHS Trust, Manchester, UK. shane.white@austin.org.au
Citation:
Phase II study of SPI-77 (sterically stabilised liposomal cisplatin) in advanced non-small-cell lung cancer. 2006, 95 (7):822-8 Br. J. Cancer
Journal:
British Journal of Cancer
Issue Date:
9-Oct-2006
URI:
http://hdl.handle.net/10541/72867
DOI:
10.1038/sj.bjc.6603345
PubMed ID:
16969346
Type:
Article
Language:
en
ISSN:
0007-0920
Appears in Collections:
All Christie Publications ; All Paterson Institute for Cancer Research

Full metadata record

DC FieldValue Language
dc.contributor.authorWhite, Shane C-
dc.contributor.authorLorigan, Paul C-
dc.contributor.authorMargison, Geoffrey P-
dc.contributor.authorMargison, Jennifer M-
dc.contributor.authorMartin, F-
dc.contributor.authorThatcher, Nick-
dc.contributor.authorAnderson, Heather-
dc.contributor.authorRanson, Malcolm R-
dc.date.accessioned2009-07-07T15:51:37Z-
dc.date.available2009-07-07T15:51:37Z-
dc.date.issued2006-10-09-
dc.identifier.citationPhase II study of SPI-77 (sterically stabilised liposomal cisplatin) in advanced non-small-cell lung cancer. 2006, 95 (7):822-8 Br. J. Canceren
dc.identifier.issn0007-0920-
dc.identifier.pmid16969346-
dc.identifier.doi10.1038/sj.bjc.6603345-
dc.identifier.urihttp://hdl.handle.net/10541/72867-
dc.description.abstractTo determine the efficacy and tolerability of SPI-77 (sterically stabilised liposomal cisplatin) at three dose levels in patients with advanced non-small-cell lung cancer (NSCLC). Patients had Stage IIIB or IV NSCLC and were chemo-naïve, and Eastern Oncology Cooperative Group 0-2. The first cohort received SPI-77 at 100 mg m-2, the second 200 mg m-2 and the final cohort 260 mg m-2. Patients had also pharmacokinetics and analysis of leucocyte platinum (Pt)-DNA adducts performed. Twenty-six patients were treated, with 22 patients being evaluable for response. Only one response occurred at the 200 mg m-2 dose level for an overall response rate of 4.5% (7.1% at >or=200 mg m-2). No significant toxicity was noted including nephrotoxicity or ototoxicity aside from two patients with Grade 3 nausea. No routine antiemetics or hydration was used. The pharmacokinetic profile of SPI-77 was typical for a liposomally formulated drug, and the AUC appeared to be proportional to the dose of SPI-77. Plasma Pt levels and leucocyte DNA adduct levels did not appear to rise with successive doses. SPI-77 demonstrates only modest activity in patients with NSCLC.en
dc.language.isoenen
dc.subjectLung Canceren
dc.subjectCancer Stagingen
dc.subject.meshAged-
dc.subject.meshArea Under Curve-
dc.subject.meshCarcinoma, Non-Small-Cell Lung-
dc.subject.meshCisplatin-
dc.subject.meshDNA Adducts-
dc.subject.meshDose-Response Relationship, Drug-
dc.subject.meshFemale-
dc.subject.meshHalf-Life-
dc.subject.meshHumans-
dc.subject.meshLeukocytes-
dc.subject.meshLung Neoplasms-
dc.subject.meshMale-
dc.subject.meshMetabolic Clearance Rate-
dc.subject.meshMiddle Aged-
dc.subject.meshNeoplasm Staging-
dc.subject.meshPlatinum-
dc.subject.meshSurvival Analysis-
dc.subject.meshTreatment Outcome-
dc.titlePhase II study of SPI-77 (sterically stabilised liposomal cisplatin) in advanced non-small-cell lung cancer.en
dc.typeArticleen
dc.contributor.departmentChristie Hospital NHS Trust, Manchester, UK. shane.white@austin.org.auen
dc.identifier.journalBritish Journal of Canceren

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