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

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...

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Bibliographic Details
Published in:Investigational new drugs 1998-01, Vol.16 (1), p.29-36
Main Authors: EINZIG, A. I, WIERNIK, P. H, WADLER, S, KAPLAN, J, BENSON, L. T, TENTORAMANO, L, TAN, V
Format: Article
Language:English
Subjects:
Adult
Aged
Anemia - chemically induced
Antineoplastic agents
Antineoplastic Agents, Phytogenic - adverse effects
Antineoplastic Agents, Phytogenic - therapeutic use
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
Bone marrow
Cancer therapies
Carcinoma, Non-Small-Cell Lung - drug therapy
Cell division
Chemotherapy
Drug dosages
Female
Granulocyte Colony-Stimulating Factor - adverse effects
Granulocyte Colony-Stimulating Factor - therapeutic use
Granulocytes
Humans
Infusions, Intravenous
Lung Neoplasms - drug therapy
Male
Medical sciences
Melanoma - drug therapy
Middle Aged
Neutropenia
Neutropenia - chemically induced
Paclitaxel - adverse effects
Paclitaxel - therapeutic use
Peripheral neuropathy
Pharmacology. Drug treatments
Regulatory approval
Toxicity
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Description
Summary: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.
ISSN:0167-6997
1573-0646
DOI:10.1023/A:1006004809169