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Brief Title: Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
Official Title: A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract
Study 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
OHSU Cancer Institute, Portland, Oregon, United States
Name: Joel R. Hecht, MD
Affiliation: Jonsson Comprehensive Cancer Center
Role: STUDY_CHAIR