NCT00198159

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (planned)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Refractory Germ Cell Tumors Expressing EGRF

Interventions

Type	Name	Description
DRUG	ZD1839 Iressa

Timeline

• Start date: 2002-09-01
• Primary completion: 2006-02-01
• Completion: 2006-03-01
• First posted: 2005-09-20
• Last updated: 2014-09-19

Locations

1 site across 1 country: United States