Phase II trial of docetaxel (Taxotere) for untreated advanced colorectal carcinoma Journal Article


Authors: Clark, T. B.; Kemeny, N. E.; Conti, J. A.; Huang, Y.; Andre, A. M.; Stockman, J.
Article Title: Phase II trial of docetaxel (Taxotere) for untreated advanced colorectal carcinoma
Abstract: 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.
Keywords: adult; cancer survival; clinical article; treatment outcome; aged; middle aged; clinical trial; neutropenia; fluorouracil; area under the curve; cancer growth; paclitaxel; phase 2 clinical trial; gastrointestinal symptom; antineoplastic agents, phytogenic; antineoplastic activity; docetaxel; colorectal carcinoma; colorectal neoplasms; cancer regression; taxoids; multidrug resistance; intravenous drug administration; diphenhydramine; hypersensitivity; humans; prognosis; human; male; female; priority journal; article; polysorbate 80
Journal Title: Cancer Investigation
Volume: 16
Issue: 5
ISSN: 0735-7907
Publisher: Informa Healthcare  
Date Published: 1998-01-01
Start Page: 314
End Page: 318
Language: English
PUBMED: 9627678
PROVIDER: scopus
DOI: 10.3109/07357909809084650
DOI/URL:
Notes: Article -- Export Date: 12 December 2016 -- Source: Scopus
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  1. Ying Huang
    22 Huang
  2. Nancy Kemeny
    543 Kemeny
  3. John A. Conti
    23 Conti