A Phase I/II Study to Evaluate Safety and Efficacy in Patients Who Have Resectable Esophageal Cancer and Are Treated With Neoadjuvant Cisplatin, Irinotecan (CPT-11) ZD1839 (IRESSA), and Radiotherapy Followed by Surgical Resection

NCT00290719 Phase 1 TERMINATED

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib together with chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I/II trial is studying the side effects of gefitinib when given together with cisplatin, irinotecan, and radiation therapy before surgery and to see how well they work in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery.

Details

Lead sponsor	University of California, San Francisco
Phase	Phase 1
Status	TERMINATED
Enrolment	6
Start date	2005-11
Completion	2008-06

Conditions

• Esophageal Cancer

Interventions

• cisplatin
• gefitinib
• irinotecan hydrochloride
• conventional surgery
• neoadjuvant therapy
• radiation therapy

Primary outcomes

• Pathological response (complete and partial) post-operatively

Countries

United States