Phase II study of SPI-77 (sterically stabilised liposomal cisplatin) in advanced non-small-cell lung cancer.
AuthorsWhite, Shane C
Lorigan, Paul C
Margison, Geoffrey P
Margison, Jennifer M
Ranson, Malcolm R
AffiliationChristie Hospital NHS Trust, Manchester, UK. firstname.lastname@example.org
MetadataShow full item record
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.
CitationPhase II study of SPI-77 (sterically stabilised liposomal cisplatin) in advanced non-small-cell lung cancer. 2006, 95 (7):822-8 Br. J. Cancer
JournalBritish Journal of Cancer
- Phase I and pharmacokinetic study of SPI-77, a liposomal encapsulated dosage form of cisplatin.
- Authors: Meerum Terwogt JM, Groenewegen G, Pluim D, Maliepaard M, Tibben MM, Huisman A, ten Bokkel Huinink WW, Schot M, Welbank H, Voest EE, Beijnen JH, Schellens JM
- Issue date: 2002 Mar
- A triplet chemotherapy with cisplatin, docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer: a phase I/II study.
- Authors: Tabata M, Kozuki T, Ueoka H, Kiura K, Harita S, Tada A, Shibayama T, Takigawa N, Yonei T, Gemba K, Segawa Y, Kishino D, Tada S, Hiraki S, Tanimoto M, Okayama Lung Cancer Study Group.
- Issue date: 2007 Jun
- Phase II study of pemetrexed disodium, a multitargeted antifolate, and cisplatin as first-line therapy in patients with advanced nonsmall cell lung carcinoma: a study of the National Cancer Institute of Canada Clinical Trials Group.
- Authors: Shepherd FA, Dancey J, Arnold A, Neville A, Rusthoven J, Johnson RD, Fisher B, Eisenhauer E
- Issue date: 2001 Aug 1
- Adaptive intrapatient dose escalation of cisplatin in combination with low-dose vp16 in patients with nonsmall cell lung cancer.
- Authors: Schellens JH, Planting AS, van Zandwijk N, Ma J, Maliepaard M, van der Burg ME, de Boer-Dennert M, Brouwer E, van der Gaast A, van den Bent MJ, Verweij J
- Issue date: 2003 Mar 24
- Phase II study of liposomal cisplatin (Lipoplatin) plus gemcitabine versus cisplatin plus gemcitabine as first line treatment in inoperable (stage IIIB/IV) non-small cell lung cancer.
- Authors: Mylonakis N, Athanasiou A, Ziras N, Angel J, Rapti A, Lampaki S, Politis N, Karanikas C, Kosmas C
- Issue date: 2010 May