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

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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.

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Authors and Affiliations

  1. Albert Einstein Cancer Center, Bronx, New York, USA

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

  2. Department of Neurology, Albert Einstein College of Medicine, Bronx, New York, USA

    Jerry Kaplan

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  1. Avi I. Einzig
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  2. Peter H. Wiernik
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  3. Scott Wadler
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  4. Jerry Kaplan
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  5. Laura T. Benson
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  6. Laura Tentoramano
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  7. Valiant Tan
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Einzig, A.I., Wiernik, P.H., Wadler, S. et al. Phase I study of paclitaxel (taxol) and granulocyte colony stimulating factor (G-CSF) in patients with unresectable malignancy. Invest New Drugs 16, 29–36 (1998). https://doi.org/10.1023/A:1006004809169

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