PMID- 15010068
OWN - NLM
STAT- MEDLINE
DCOM- 20040519
LR  - 20151119
IS  - 0959-8049 (Print)
IS  - 0959-8049 (Linking)
VI  - 40
IP  - 5
DP  - 2004 Mar
TI  - Real-time pharmacokinetics guiding clinical decisions; phase I study of a weekly 
      schedule of liposome encapsulated paclitaxel in patients with solid tumours.
PG  - 681-8
AB  - The purpose of this weekly schedule phase I study of liposome encapsulated 
      paclitaxel (LEP) was to define the maximum-tolerated dose (MTD), the recommended 
      dose (RD), the dose-limiting toxicities (DLTs), the pharmacokinetic profiles, and 
      to evaluate preliminarily antitumour effects in patients with refractory solid 
      malignancies. LEP was administered as an intravenous (i.v.) infusion over 45 min 
      once every week for 6 out of 8 weeks. Fourteen patients were treated at doses 
      ranging from 90 to 150 mg/m(2)/week. In one patient, DLT was observed at the dose 
      level of 150 mg/m(2)/week, who received less than 70% of the intended cumulative 
      dose. No cumulative toxicities were observed. Stabilisation of disease for 8 
      weeks was documented in two patients. The whole blood clearance of total 
      paclitaxel was similar for LEP (15.3+/-8.98 l/h/m(2)) and Taxol (17.5+/-3.43 
      l/h/m(2)), and the extraliposomal to total drug ratio increased rapidly to unity 
      at later sampling time points. The trial was discontinued upon completion of 
      enrolment of the 150 mg/m(2)/week cohort because an assessment of the 
      pharmacokinetics and clinical data suggested that LEP was unlikely to have any 
      advantages over Taxol. It is concluded that this formulation of LEP is unlikely 
      to provide improvements over the taxanes currently in clinical use.
FAU - Soepenberg, O
AU  - Soepenberg O
AD  - Department of Medical Oncology, Erasmus University Medical Center-Daniel den Hoed 
      Cancer Center, Groene Hilledijk 301, 3075 EA Rotterdam, PO Box 5201, 3008 AE 
      Rotterdam, The Netherlands. o.soepenberg@erasmusmc.nl
FAU - Sparreboom, A
AU  - Sparreboom A
FAU - de Jonge, M J A
AU  - de Jonge MJ
FAU - Planting, A S Th
AU  - Planting AS
FAU - de Heus, G
AU  - de Heus G
FAU - Loos, W J
AU  - Loos WJ
FAU - Hartman, C M
AU  - Hartman CM
FAU - Bowden, C
AU  - Bowden C
FAU - Verweij, J
AU  - Verweij J
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Journal Article
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Antineoplastic Agents, Phytogenic)
RN  - 0 (Liposomes)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Analysis of Variance
MH  - Antineoplastic Agents, Phytogenic/adverse effects/*pharmacokinetics
MH  - Cohort Studies
MH  - Decision Making
MH  - Disease Progression
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Half-Life
MH  - Humans
MH  - Infusions, Intravenous
MH  - Liposomes
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Neoplasms/*drug therapy
MH  - Paclitaxel/adverse effects/*pharmacokinetics
MH  - Treatment Outcome
EDAT- 2004/03/11 05:00
MHDA- 2004/05/20 05:00
CRDT- 2004/03/11 05:00
PHST- 2003/11/12 00:00 [received]
PHST- 2003/11/21 00:00 [accepted]
PHST- 2004/03/11 05:00 [pubmed]
PHST- 2004/05/20 05:00 [medline]
PHST- 2004/03/11 05:00 [entrez]
AID - S0959804904000061 [pii]
AID - 10.1016/j.ejca.2003.11.027 [doi]
PST - ppublish
SO  - Eur J Cancer. 2004 Mar;40(5):681-8. doi: 10.1016/j.ejca.2003.11.027.