A Phase I Study of Gemcitabine and Docetaxel for Advanced Stage Solid Tumors

Background: We conducted a phase I study to determine the maximum tolerated dose of docetaxel in combination with gemcitabine for patients with refractory solid tumors. Methods: From January 1998 to November 1999, we treated 28 patients on a phase I protocol with gemcitabine given at a constant dose...

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Bibliographic Details
Published in:Cancer investigation 2003-01, Vol.21 (3), p.350-354
Main Authors: Poole, Michael E., Bernard, Stephen A., Churchel, Mary Ann, Weissler, Mark C., Calvo, Benjamin, Cance, William, Ollila, David, Koruda, Mark, Behrns, Kevin, Detterbeck, Frank C.
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic agents
Antineoplastic Agents - adverse effects
Biological and medical sciences
Chemotherapy
Deoxycytidine - adverse effects
Deoxycytidine - analogs & derivatives
Dose-Response Relationship, Drug
Female
Humans
Male
Medical sciences
Middle Aged
Neoplasms - classification
Neoplasms - drug therapy
Neoplasms - pathology
Paclitaxel - adverse effects
Paclitaxel - analogs & derivatives
Patient Selection
Pharmacology. Drug treatments
Taxoids
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Summary:Background: We conducted a phase I study to determine the maximum tolerated dose of docetaxel in combination with gemcitabine for patients with refractory solid tumors. Methods: From January 1998 to November 1999, we treated 28 patients on a phase I protocol with gemcitabine given at a constant dose of 800 mg m2 IV over 30 minutes on days 1, 8, and 15. Docetaxel was administered by a phase I schedule over 1 hour on day 1 of a 28-day cycle with a starting dose of 50 mg m2 and increased by increments of 10 mg m2 based on dose-limiting toxicity (DLT) that occurred in the first cycle. Results: Neutropenia and thrombocytopenia were the dose-limiting toxicities. The maximum tolerated dose was 60 mg m2. The most significant nonhematologic toxicities included fatigue, nausea, vomiting, mucositis, and hypersensitivity reactions. There was one partial response at 15 months in a patient with gastric cancer and six patients with stable disease for 4.0 to 15.0 months. Conclusions: The maximum tolerated dose of docetaxel with gemcitabine is 60 mg m2. A phase II study in selected primary sites is planned.
ISSN:0735-7907
1532-4192
DOI:10.1081/CNV-120018225