The absolute bioavailability of oral vinorelbine in patients with solid tumors

Richard M. Lush, Jeannine S. McCune, Leticia Tetteh, John A. Thompson, J. J. Mahany, Linda L Garland, A. Benjamin Suttle, Daniel M. Sullivan

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Due to advances in the methods used to quantitate vinorelbine, this study was conducted to characterize fully the bioavailability of an oral dosage form of vinorelbine. Twenty-seven eligible patients with solid tumors were enrolled onto this study and were treated in a randomized crossover design to receive either 70 mg/m2 orally or 30 mg/m2 intravenously followed by the alternative treatment one week later. Vinorelbine was administered orally as a soft-gelatin capsule. Pharmacokinetic sampling was carried out for 7 days following each dose. Whole blood vinorelbine concentrations were measured using a sensitive LC/MS/MS method. The data from patients were excluded if they vomited within 3 h after the oral dose. Results: Three subjects were removed from study following the first dose due to safety reasons. Of the remaining 24 subjects, five experienced vomiting within 3 h of oral dosing. Total body clearance calculated from the intravenous dose was 43.65 L/h (±10.9) and the terminal half-life was estimated to be 49 h. Using complete data from the remaining 19 subjects, the mean absolute bioavailability of the oral dosage formulation of vinorelbine was calculated to be 33% (±18%). In conclusion we have characterized the pharmacokinetics of both orally administered and intravenous vinorelbine over 7 days after administration and have determined the mean oral bioavailability of this oral formulation to be 33%.

Original languageEnglish (US)
Pages (from-to)578-584
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume56
Issue number6
DOIs
StatePublished - Dec 2005

Fingerprint

Biological Availability
Tumors
Neoplasms
Pharmacokinetics
Dosage Forms
Gelatin
Cross-Over Studies
Capsules
Vomiting
Half-Life
vinorelbine
Blood
Sampling
Safety

Keywords

  • Bioavailability
  • Elderly
  • Pharmacokinetics
  • Vinorelbine

ASJC Scopus subject areas

  • Cancer Research
  • Pharmacology
  • Oncology

Cite this

Lush, R. M., McCune, J. S., Tetteh, L., Thompson, J. A., Mahany, J. J., Garland, L. L., ... Sullivan, D. M. (2005). The absolute bioavailability of oral vinorelbine in patients with solid tumors. Cancer Chemotherapy and Pharmacology, 56(6), 578-584. https://doi.org/10.1007/s00280-005-1025-0

The absolute bioavailability of oral vinorelbine in patients with solid tumors. / Lush, Richard M.; McCune, Jeannine S.; Tetteh, Leticia; Thompson, John A.; Mahany, J. J.; Garland, Linda L; Suttle, A. Benjamin; Sullivan, Daniel M.

In: Cancer Chemotherapy and Pharmacology, Vol. 56, No. 6, 12.2005, p. 578-584.

Research output: Contribution to journalArticle

Lush, RM, McCune, JS, Tetteh, L, Thompson, JA, Mahany, JJ, Garland, LL, Suttle, AB & Sullivan, DM 2005, 'The absolute bioavailability of oral vinorelbine in patients with solid tumors', Cancer Chemotherapy and Pharmacology, vol. 56, no. 6, pp. 578-584. https://doi.org/10.1007/s00280-005-1025-0
Lush, Richard M. ; McCune, Jeannine S. ; Tetteh, Leticia ; Thompson, John A. ; Mahany, J. J. ; Garland, Linda L ; Suttle, A. Benjamin ; Sullivan, Daniel M. / The absolute bioavailability of oral vinorelbine in patients with solid tumors. In: Cancer Chemotherapy and Pharmacology. 2005 ; Vol. 56, No. 6. pp. 578-584.
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