A sensitive docetaxel assay in plasma by solid-phase extraction and high performance liquid chromatography-UV detection: validation and suitability in phase I clinical trial pharmacokinetics

Invest New Drugs. 1999;17(4):325-33. doi: 10.1023/a:1006327302041.

Abstract

We have developed a specific and sensitive method aiming at docetaxel (Taxotere) determination in plasma of treated patients. This involved solid-phase extraction of 1 ml of plasma onto carboxylic acid (CBA) grafted silica cartridges followed by reversed-phase liquid chromatography with UV detection. The best selectivity was obtained through the use of C18 Uptisphere as stationary phase. The low limit of quantitation obtained (LOQ: 5 ng/ml) allowed measurements of docetaxel up to 24 hours after one-hour infusions with low dosages of drug (60 mg/m2). The method was applied successfully to monitor docetaxel plasma levels within two protocols associating fixed dosages of either methotrexate or gemcitabine with escalating doses of Taxotere.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antimetabolites, Antineoplastic / administration & dosage
  • Antimetabolites, Antineoplastic / blood
  • Antineoplastic Agents, Phytogenic / blood*
  • Antineoplastic Combined Chemotherapy Protocols
  • Calibration
  • Chromatography, High Pressure Liquid
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Deoxycytidine / blood
  • Docetaxel
  • Gemcitabine
  • Humans
  • Methotrexate / administration & dosage
  • Methotrexate / blood
  • Paclitaxel / analogs & derivatives*
  • Paclitaxel / blood
  • Reproducibility of Results
  • Solvents
  • Spectrophotometry, Ultraviolet
  • Taxoids*

Substances

  • Antimetabolites, Antineoplastic
  • Antineoplastic Agents, Phytogenic
  • Solvents
  • Taxoids
  • Deoxycytidine
  • Docetaxel
  • Paclitaxel
  • Methotrexate
  • Gemcitabine