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Brief Title: Cisplatin and Irinotecan Chemotherapy, Followed by ZD 1839 (Iressa) in Patients With Esophageal or Gastric Carcinomas
Official Title: 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
Study ID: NCT00215995
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Ponce School of Medicine, Ponce, , Puerto Rico
University of Puetro Rico Cancer Center, San Juan, , Puerto Rico
Name: Chris Garrett, MD
Affiliation: H. Lee Moffitt Cancer Center
Role: PRINCIPAL_INVESTIGATOR