Clinical Trial: A Phase II Study of Iressa in Patients With Chemo Refractory Germ Cell Tumors Expressing EGFR

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Study of ZD1839 (Iressa)in Chemotherapy Refractory Germ Cell Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

Brief Summary: This study will evaluate the use of ZD1839 in the treatment of subjects with refractory germ cell tumors. Subjects will take ZD1839 for one year in the absence of excessive toxicity or decision to withdraw.

Detailed Summary: The primary objective is to determine the response rate of ZD1839 in patients with refractory germ cell tumors expressing EGFR. The secondary objectives are to determine the duration of response, time to progression and overall survival in patients with refractory germ cell tumors expressing EGFR and treated with ZD1839; to evaluate the tolerability of ZD1839 in patients with refractory germ cell tumors and to correlate tumor response to degree of EGFR expression by immunohistochemistry.
Sponsor: Indiana University School of Medicine

Current Primary Outcome: To determine the response rate of ZD1839

Original Primary Outcome: Same as current

Current Secondary Outcome: To determine duration of response, time to progression and overall survival

Original Secondary Outcome: Same as current

Information By: Indiana University

Dates:
Date Received: September 8, 2005
Date Started: September 2002
Date Completion:
Last Updated: September 18, 2014
Last Verified: September 2014