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Intravenous administration of CP-4055 (ELACYT (TM)) in patients with solid tumours. A phase I study

Dueland, Svein; Aamdal, Steinar; Lind, Michael J.; Thomas, Hilary; Sandvold, Marit Liland; Gaullier, Jean-Michel; Rasch, Wenche

Authors

Svein Dueland

Steinar Aamdal

Professor Michael Lind M.J.Lind@hull.ac.uk
Foundation Professor of Oncology/ Head of the Joint Centre for Cancer Studies

Hilary Thomas

Marit Liland Sandvold

Jean-Michel Gaullier

Wenche Rasch



Abstract

Purpose. Cytarabine (ara-C) has limited activity in solid tumours. CP-4055 (ELACYTT) is a novel ara-C-5'-elaidic acid ester that may circumvent this limitation. CP-4055 maximum tolerated dose (MTD), pharmacokinetics and antitumor activity have been investigated in patients with solid tumours. Material and methods. Thirty-four patients (19 malignant melanoma, 8 ovarian cancers and 7 NSCLC) received CP-4055 as a 30 min, or 2 hr intravenous (IV) infusion daily for 5 consecutive days every 3 or 4 weeks (D1-5 q3w or D1-5 q4w) in a dose escalation designed study with doses ranging from 30 to 240 mg/m2/day. Results. The most frequent CTC grade 1-2 adverse events (AEs) were nausea, fatigue, vomiting, anorexia and pyrexia. Most of the grade 3-4 AEs were neutropenia. The MTD was 200 mg/m2/day and 240 mg/m2/day for D1-5 q3w and D1-5 q4w, respectively. The MTD was independent of infusion time in the 4 week schedule. CP-4055 was maintained in plasma for up to 5-10 hr at dose levels >150 mg/m2/day. One objective partial response (PR) with time to progression (TTP) of 22 months was reported in an advanced malignant melanoma patient. Conclusion. CP-4055 was well tolerated; the majority of the AEs were of CTC grade 1. The 3 week schedule was not recommended due to neutropenic nadir between days 18-26. The recommended dose was 200 mg/m2/day in a D1-5 q4w schedule. Efficacy data suggest that CP-4055 might be active in treatment of solid tumours.

Journal Article Type Article
Publication Date Jan 1, 2009
Journal Acta Oncologica
Print ISSN 0284-186X
Electronic ISSN 1651-226X
Publisher Taylor & Francis
Peer Reviewed Peer Reviewed
Volume 48
Issue 1
Pages 137-145
APA6 Citation Dueland, S., Aamdal, S., Lind, M. J., Thomas, H., Sandvold, M. L., Gaullier, J., & Rasch, W. (2009). Intravenous administration of CP-4055 (ELACYT (TM)) in patients with solid tumours. A phase I study. Acta oncologica, 48(1), 137-145. doi:10.1080/02841860802183620
DOI https://doi.org/10.1080/02841860802183620
Keywords Oncology; Radiology Nuclear Medicine and imaging; Hematology; General Medicine
Publisher URL http://www.ingentaconnect.com/content/apl/sonc/2009/00000048/00000001/art00018
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