Phase I study of paclitaxel (taxol) and granulocyte colony stimulating factor (G-CSF) in patients with unresectable malignancy

Avi I. Einzig, Peter H. Wiernik, Scott Wadler, Jerry Kaplan, Laura T. Benson, Laura Tentoramano, Valiant Tan

Research output: Contribution to journalArticle

15 Scopus citations

Abstract

A phase I trial of a 24-hour infusion of paclitaxel was conducted to identify the maximum tolerated dose of paclitaxel with granulocyte colony-stimulating factor (G-CSF) in patients with unresectable malignancy previously untreated with chemotherapy. Nineteen patients with metastatic melanoma or non-small cell lung cancer were treated with paclitaxel administered at 250, 300, 400 mg/m2 every 3 weeks. G-CSF 5 μg/kg was given as a daily subcutaneous injection 24 hours after the completion of the infusion. Dose limiting myelosuppression and peripheral neuropathy was observed at 400 mg/m2 and 350 mg/m2. Paclitaxel can be safely administered as a 24-hour infusion at 300 mg/m2 with G-CSF. Further studies of paclitaxel and G-CSF are recommended to determine a dose-response relationship in sensitive tumors.

Original languageEnglish (US)
Pages (from-to)29-36
Number of pages8
JournalInvestigational New Drugs
Volume16
Issue number1
DOIs
StatePublished - Aug 28 1998

Keywords

  • Paclitaxel (taxol) and G-CSF

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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