Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-24 @ 12:11 PM
NCT ID:
NCT00020761
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and paclitaxel in treating patients who have metastatic or recurrent cancer of the esophagus or stomach.
Detailed Description:
OBJECTIVES:
* Determine the antitumor activity of irinotecan and paclitaxel in patients with metastatic or recurrent adenocarcinoma of the esophagus or stomach.
* Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia vs adenocarcinoma of the rest of the stomach).
Patients receive irinotecan IV over 90 minutes followed by paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 26-54 patients (13-27 per stratum) will be accrued for this study.
Study:
NCT00020761
Study Brief:
Protocol Section:
NCT00020761