Gastric Cancer Clinical Trial
Official title:
A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract
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.
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.
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