Phase II study of SPI-77 (sterically stabilised liposomal cisplatin) in advanced non-small-cell lung cancer.
Authors
White, Shane CLorigan, Paul C
Margison, Geoffrey P
Margison, Jennifer M
Martin, F
Thatcher, Nick
Anderson, Heather
Ranson, Malcolm R
Affiliation
Christie Hospital NHS Trust, Manchester, UK. shane.white@austin.org.auIssue Date
2006-10-09
Metadata
Show full item recordAbstract
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.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. CancerJournal
British Journal of CancerDOI
10.1038/sj.bjc.6603345PubMed ID
16969346Type
ArticleLanguage
enISSN
0007-0920ae974a485f413a2113503eed53cd6c53
10.1038/sj.bjc.6603345