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 microg/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.
Publication types
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Clinical Trial
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Clinical Trial, Phase I
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Research Support, U.S. Gov't, P.H.S.
MeSH terms
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Adult
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Aged
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Anemia / chemically induced
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Antineoplastic Agents, Phytogenic / adverse effects*
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Antineoplastic Agents, Phytogenic / therapeutic use
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Antineoplastic Combined Chemotherapy Protocols / adverse effects*
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use
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Carcinoma, Non-Small-Cell Lung / drug therapy*
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Female
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Granulocyte Colony-Stimulating Factor / adverse effects*
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Granulocyte Colony-Stimulating Factor / therapeutic use
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Humans
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Infusions, Intravenous
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Lung Neoplasms / drug therapy*
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Male
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Melanoma / drug therapy*
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Middle Aged
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Neutropenia / chemically induced
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Paclitaxel / adverse effects*
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Paclitaxel / therapeutic use
Substances
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Antineoplastic Agents, Phytogenic
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Granulocyte Colony-Stimulating Factor
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Paclitaxel