Medpedia

• Refractory Germ Cell Tumors Expressing EGRF

Inclusion Criteria:
-  Histologic or serologic proof of metastatic germ cell neoplasm(gonadal or
extragonadal primary) with disease not amenable to cure with either surgery or
chemotherapy. Patients w/ seminoma and non-seminoma are eligible, as are women w/
ovarian germ cell tumors.
-  Evidence of recurrent or metastatic carcinoma
-  Must have received initial cisplatin combination therapy & demonstrated progression
following the administration of at least one "salvage" regimen for advanced germ cell
neoplasms.
-  Patients are eligible after first line platinum bsed chemotherapy if their disease
has relapsed and they have primary mediastinal non seminomatous germ cell tumor, late
relapse or progressed w/in 4 wks of last platinum dose.
-  immunohistochemical documentation of EGFR expression documented.
-  adequate organ function: ANC >/=150,plt >100K, total bili normal(ULN). Pts w/ liver mets up to 3x ULN.Transaminases up to 1.5 x ULN if alk phos
is mets may have alk phos up to 5x ULN. Serum crt -  ECOG performance status 0-2.
Exclusion Criteria:
-  Must be 3 weeks post major surgery,  radiotherapy, or chemotherapy and hae recovered
from all toxicity.
-  Active unresolved infection and/or are receiving concurrent treatment with parenteral
antibiotics are ineligible.
-  Patients requiring steroids for symptomatic brain metastasis are not eligible.
-  Pregnant or lactating patients are not eligible.
-  Class III/IV heart disease

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.

• Drug: ZD1839 Iressa

• To determine the response rate of ZD1839
  Safety Issue: No
• To determine duration of response, time to progression and overall survival
  Safety Issue: No

• Lawrence Einhorn, M
  Principal Investigator, Indiana University

• Indiana University Cancer Center
  Indianapolis, Indiana, 46202, United States
  Withdrawn

• Indiana University School of Medicine
  Lead Sponsor
• United States: Food and Drug Administration