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

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

Research output: Contribution to journalArticle

15 Citations (Scopus)

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

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Granulocyte Colony-Stimulating Factor
Paclitaxel
Neoplasms
Maximum Tolerated Dose
Peripheral Nervous System Diseases
Subcutaneous Injections
Non-Small Cell Lung Carcinoma
Melanoma
Drug Therapy

Keywords

  • Paclitaxel (taxol) and G-CSF

ASJC Scopus subject areas

  • Molecular Medicine
  • Pharmacology

Cite this

Phase I study of paclitaxel (taxol) and granulocyte colony stimulating factor (G-CSF) in patients with unresectable malignancy. / Einzig, Avi Israel; Wiernik, Peter H.; Wadler, Scott; Kaplan, Jerry; Benson, Laura T.; Tentoramano, Laura; Tan, Valiant.

In: Investigational New Drugs, Vol. 16, No. 1, 28.08.1998, p. 29-36.

Research output: Contribution to journalArticle

Einzig, Avi Israel ; Wiernik, Peter H. ; Wadler, Scott ; Kaplan, Jerry ; Benson, Laura T. ; Tentoramano, Laura ; Tan, Valiant. / Phase I study of paclitaxel (taxol) and granulocyte colony stimulating factor (G-CSF) in patients with unresectable malignancy. In: Investigational New Drugs. 1998 ; Vol. 16, No. 1. pp. 29-36.
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