NCT00215995

Cisplatin and Irinotecan Chemotherapy, Followed by ZD 1839 (Iressa) in Patients With Esophageal or Gastric Carcinomas

A Phase II Study of Cisplatin and Irinotecan Induction Chemotherapy, Followed by ZD 1839 (IRESSA) in Adult Patients With Surgically Unresectable and/or Metastatic Esophageal or Gastric Carcinomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is for patients with esophageal, esophagogastric, or gastric cancer that has spread to other parts of the body. The purpose of this study is to test the safety and effectiveness of a new experimental drug called ZD 1839 following initial therapy with two other chemotherapy drugs, called Irinotecan (CPT-11) and Cisplatin.

Detailed description

This is an open-label, non-randomized, multicenter Phase II study designed to evaluate tumor response rates in patients with surgically unresectable and/or metastatic esophageal, esophagogastric, and gastric adenocarcinoma or squamous carcinoma. Study schema is as follows. Patients will receive Irinotecan and Cisplatin on days 1 and 8 every 21 days for a maximum of 6 cycles of therapy. This is then followed by ZD 1839 (Iressa), which is an oral pill taken once daily. During the Iressa phase, patients will be evaluated every 6 weeks. This includes labs, CT scans and physical examination. The exploratory objective of the study is to examine the correlation between epidermal growth factor receptor (EGFR) expression and radiographic response to treatment.

Conditions

• Esophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	As outlined in Detailed Description
DRUG	Irinotecan	As outlined in Detailed Description
DRUG	ZD 1839	As outlined in Detailed Description

Timeline

• Start date: 2003-07-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2005-09-22
• Last updated: 2012-01-13

Locations

3 sites across 2 countries: United States, Puerto Rico