NCT00020761

Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach

A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	irinotecan hydrochloride	The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met. Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks.
DRUG	paclitaxel	The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met. Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks.

Timeline

• Start date: 2000-04-01
• Primary completion: 2002-12-01
• Completion: 2005-08-01
• First posted: 2003-01-27
• Last updated: 2020-08-03

Locations

4 sites across 1 country: United States