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Docetaxel and Irinotecan in Treating Patients With Advanced Cancer of the Esophagus or Stomach

2014-08-27 03:58:19 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and irinotecan in treating patients who have advanced cancer of the esophagus or stomach.

Description

OBJECTIVES: I. Determine the objective tumor response rate in patients with advanced adenocarcinoma of the lower esophagus, esophagogastric junction, and gastric cardia treated with docetaxel and irinotecan. II. Determine time to progression and overall survival of patients treated treated with this regimen. III. Determine the toxic effects of this regimen in these patients. IV. Assess treatment response in these patients by determining the prevalence of dysphagia, anorexia, and swallowing ability at diagnosis and during treatment with this regimen.

OUTLINE: Patients receive irinotecan IV over 90 minutes followed by docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression. Patients achieving a complete response (CR) receive 2 additional courses after CR. Patients experiencing disease progression after a CR and 2 additional courses may be retreated with irinotecan and docetaxel. Dysphagia, anorexia, and swallowing ability are assessed before the first course of treatment and then at each tumor assessment. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 12-26 months.

Study Design

Primary Purpose: Treatment

Conditions

Esophageal Cancer

Intervention

docetaxel, irinotecan hydrochloride

Location

CCOP - Scottsdale Oncology Program
Scottsdale
Arizona
United States
85259-5404

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:19-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the ESOPHAGUS.

A pathological condition characterized by the presence of a number of ESOPHAGEAL DIVERTICULA in the ESOPHAGUS.

Surgical incision of the lower esophageal sphincter near the CARDIA often used to treat ESOPHAGEAL ACHALASIA.

Circular innermost layer of the ESOPHAGUS wall that mediates esophageal PERISTALSIS which pushes ingested food bolus toward the stomach.

A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.

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