Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: The Eastern Cooperative Oncology Group (ECOG) results of protocol E1293

Avi Israel Einzig, Donna Neuberg, Scot C. Remick, Daniel D. Karp, Peter J. O'Dwyer, James A. Stewart, Al B. Benson

Research output: Contribution to journalArticle

181 Citations (Scopus)

Abstract

The aim of this study was to evaluate the clinical efficacy and safety of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy. Docetaxel 100 mg m-2 was administered as a 1 hour intravenous (IV) infusion every 3 weeks to 41 patients. Patients were premedicated prior to each course with dexamethasone, diphenhydramine and cimetidine. Clinical response and toxicity were determined. Objective responses were seen in seven of 41 eligible patients (two complete responses [CRs] and five partial responses [PRs], for an objective response rate of 17% (90% confidence interval [CI], 8% to 30%). The most common toxicity was grade 4 neutropenia, which occurred in 88% of patients; 46% of patients required a dose reduction following an episode of neutropenic fever requiring antibiotic therapy. Additional patients have had reversible grade 3-4 toxicities including nausea, vomiting, stomatitis, diarrhea, fatigue and peripheral neuropathy. Ten patients have had grade 1-3 hypersensitivity reactions. Alopecia has been seen in the majority of patients. Fluid retention grade 1-3 has been observed in patients. Docetaxel administered on this schedule is an active agent in adenocarcinomas of the upper gastrointestinal tract. Further investigation of this drug should be conducted in multi-drug combination programs.

Original languageEnglish (US)
Pages (from-to)87-93
Number of pages7
JournalMedical Oncology
Volume13
Issue number2
DOIs
StatePublished - Jan 1 1996

Fingerprint

docetaxel
Upper Gastrointestinal Tract
Adenocarcinoma
Drug Therapy
Diphenhydramine
Stomatitis
Cimetidine
Alopecia

Keywords

  • Adenocarcinoma of upper gastrointestinal tract
  • Docetaxel

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy : The Eastern Cooperative Oncology Group (ECOG) results of protocol E1293. / Einzig, Avi Israel; Neuberg, Donna; Remick, Scot C.; Karp, Daniel D.; O'Dwyer, Peter J.; Stewart, James A.; Benson, Al B.

In: Medical Oncology, Vol. 13, No. 2, 01.01.1996, p. 87-93.

Research output: Contribution to journalArticle

@article{31fd123207964a8fb708be5b3db26dd2,
title = "Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: The Eastern Cooperative Oncology Group (ECOG) results of protocol E1293",
abstract = "The aim of this study was to evaluate the clinical efficacy and safety of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy. Docetaxel 100 mg m-2 was administered as a 1 hour intravenous (IV) infusion every 3 weeks to 41 patients. Patients were premedicated prior to each course with dexamethasone, diphenhydramine and cimetidine. Clinical response and toxicity were determined. Objective responses were seen in seven of 41 eligible patients (two complete responses [CRs] and five partial responses [PRs], for an objective response rate of 17{\%} (90{\%} confidence interval [CI], 8{\%} to 30{\%}). The most common toxicity was grade 4 neutropenia, which occurred in 88{\%} of patients; 46{\%} of patients required a dose reduction following an episode of neutropenic fever requiring antibiotic therapy. Additional patients have had reversible grade 3-4 toxicities including nausea, vomiting, stomatitis, diarrhea, fatigue and peripheral neuropathy. Ten patients have had grade 1-3 hypersensitivity reactions. Alopecia has been seen in the majority of patients. Fluid retention grade 1-3 has been observed in patients. Docetaxel administered on this schedule is an active agent in adenocarcinomas of the upper gastrointestinal tract. Further investigation of this drug should be conducted in multi-drug combination programs.",
keywords = "Adenocarcinoma of upper gastrointestinal tract, Docetaxel",
author = "Einzig, {Avi Israel} and Donna Neuberg and Remick, {Scot C.} and Karp, {Daniel D.} and O'Dwyer, {Peter J.} and Stewart, {James A.} and Benson, {Al B.}",
year = "1996",
month = "1",
day = "1",
doi = "10.1007/BF02993858",
language = "English (US)",
volume = "13",
pages = "87--93",
journal = "Medical Oncology and Tumor Pharmacotherapy",
issn = "0340-7004",
publisher = "Springer Science and Business Media Deutschland GmbH",
number = "2",

}

TY - JOUR

T1 - Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy

T2 - The Eastern Cooperative Oncology Group (ECOG) results of protocol E1293

AU - Einzig, Avi Israel

AU - Neuberg, Donna

AU - Remick, Scot C.

AU - Karp, Daniel D.

AU - O'Dwyer, Peter J.

AU - Stewart, James A.

AU - Benson, Al B.

PY - 1996/1/1

Y1 - 1996/1/1

N2 - The aim of this study was to evaluate the clinical efficacy and safety of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy. Docetaxel 100 mg m-2 was administered as a 1 hour intravenous (IV) infusion every 3 weeks to 41 patients. Patients were premedicated prior to each course with dexamethasone, diphenhydramine and cimetidine. Clinical response and toxicity were determined. Objective responses were seen in seven of 41 eligible patients (two complete responses [CRs] and five partial responses [PRs], for an objective response rate of 17% (90% confidence interval [CI], 8% to 30%). The most common toxicity was grade 4 neutropenia, which occurred in 88% of patients; 46% of patients required a dose reduction following an episode of neutropenic fever requiring antibiotic therapy. Additional patients have had reversible grade 3-4 toxicities including nausea, vomiting, stomatitis, diarrhea, fatigue and peripheral neuropathy. Ten patients have had grade 1-3 hypersensitivity reactions. Alopecia has been seen in the majority of patients. Fluid retention grade 1-3 has been observed in patients. Docetaxel administered on this schedule is an active agent in adenocarcinomas of the upper gastrointestinal tract. Further investigation of this drug should be conducted in multi-drug combination programs.

AB - The aim of this study was to evaluate the clinical efficacy and safety of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy. Docetaxel 100 mg m-2 was administered as a 1 hour intravenous (IV) infusion every 3 weeks to 41 patients. Patients were premedicated prior to each course with dexamethasone, diphenhydramine and cimetidine. Clinical response and toxicity were determined. Objective responses were seen in seven of 41 eligible patients (two complete responses [CRs] and five partial responses [PRs], for an objective response rate of 17% (90% confidence interval [CI], 8% to 30%). The most common toxicity was grade 4 neutropenia, which occurred in 88% of patients; 46% of patients required a dose reduction following an episode of neutropenic fever requiring antibiotic therapy. Additional patients have had reversible grade 3-4 toxicities including nausea, vomiting, stomatitis, diarrhea, fatigue and peripheral neuropathy. Ten patients have had grade 1-3 hypersensitivity reactions. Alopecia has been seen in the majority of patients. Fluid retention grade 1-3 has been observed in patients. Docetaxel administered on this schedule is an active agent in adenocarcinomas of the upper gastrointestinal tract. Further investigation of this drug should be conducted in multi-drug combination programs.

KW - Adenocarcinoma of upper gastrointestinal tract

KW - Docetaxel

UR - http://www.scopus.com/inward/record.url?scp=0030451795&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0030451795&partnerID=8YFLogxK

U2 - 10.1007/BF02993858

DO - 10.1007/BF02993858

M3 - Article

C2 - 9013471

AN - SCOPUS:0030451795

VL - 13

SP - 87

EP - 93

JO - Medical Oncology and Tumor Pharmacotherapy

JF - Medical Oncology and Tumor Pharmacotherapy

SN - 0340-7004

IS - 2

ER -