Phase II Trial of Docetaxel (Taxotere®) for Untreated Advanced Colorectal Carcinoma

Phase II Trial of Docetaxel (Taxotere®) for Untreated Advanced Colorectal Carcinoma

The antimicrotubule agent docetaxel (Taxotere®), a semisynthetic taxoid, has demonstrated antitumor activity against colorectal cancer cell lines in vitro, and in murine tumor models. We sought to characterize its activity in a group of previously untreated patients with colorectal carcinoma. Eighte...

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Bibliographic Details
Published in:Cancer investigation Vol. 16; no. 5; pp. 314 - 318
Main Authors: Clark, Torey B., Kemeny, Nancy E., Conti, John A., Huang, Ying, Andre, A. McKenzie, Stockman, Jennifer
Format: Journal Article
Language:English
Published: New York, NY Informa UK Ltd 1998
Taylor & Francis
Informa Healthcare
Subjects:
Adult
Aged
Antineoplastic agents
Antineoplastic Agents, Phytogenic - therapeutic use
Biological and medical sciences
Chemotherapy
Colorectal Neoplasms - drug therapy
Female
Humans
Male
Medical sciences
Middle Aged
Paclitaxel - adverse effects
Paclitaxel - analogs & derivatives
Paclitaxel - pharmacokinetics
Paclitaxel - therapeutic use
Pharmacology. Drug treatments
Taxoids
Antineoplastic agent
Human
Pharmacokinetic pharmacodynamic relationship
Rectal disease
Toxicity
Docetaxel
Malignant tumor
Colonic disease
Chemotherapy
Treatment
Taxane derivatives
Phase II trial
Rectum
Digestive diseases
Intestinal disease
Advanced stage
Colon
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Summary:The antimicrotubule agent docetaxel (Taxotere®), a semisynthetic taxoid, has demonstrated antitumor activity against colorectal cancer cell lines in vitro, and in murine tumor models. We sought to characterize its activity in a group of previously untreated patients with colorectal carcinoma. Eighteen previously untreated patients with advanced, measurable colorectal carcinoma were treated with a 60-min intravenous infusion of docetaxel with a dose of 100 mg/m2 administered every 21 days. Routine premedication with diphenhydramine was given. Patients were required to have normal organ function and a Karnofsky performance status (KPS) ≥ 60%. No complete responses (CR) or partial responses (PR) were observed. Median survival was 13 months, despite a median time to progression of only 1.3 months. Neutropenia was the most common dose-limiting toxicity, resulting in 5 episodes of febrile neutropenia requiring hospitalization and intravenous antibiotics. One patient experienced a grade 4 hypersensitivity reaction (HSR) requiring treatment termination. No toxic deaths occurred. Despite encouraging preclinical data, docetaxel is an inactive drug in advanced colorectal cancer when given in the dose and on the schedule examined in the present study, and has significant, although reversible, toxicities.
ISSN:0735-7907
1532-4192
DOI:10.3109/07357909809084650