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

Purpose

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.

Condition	Intervention	Phase
Refractory Germ Cell Tumors Expressing EGRF	Drug: ZD1839 Iressa	Phase II

MedlinePlus related topics:

Cancer

Drug Information available for:

ZD1839 Epidermal Growth Factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

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

Further study details as provided by Indiana University:

Primary Outcome Measures:

To determine the response rate of ZD1839

Secondary Outcome Measures:

To determine duration of response, time to progression and overall survival

Estimated Enrollment:	21
Study Start Date:	September 2002
Estimated Study Completion Date:	March 2006

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.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 </= upper limit of normal(ULN). Pts w/ liver mets up to 3x ULN.Transaminases up to 1.5 x ULN if alk phos is </=ULN or alk phos may be up to 4x ULN if transaminases are </= ULN. Pts w/ liver mets may have alk phos up to 5x ULN. Serum crt </= 2.0.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198159

Locations


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

Sponsors and Collaborators

Indiana University School of Medicine

AstraZeneca

Investigators


Principal Investigator:	Lawrence Einhorn, M	Indiana University

More Information

Study ID Numbers:	0211-07
First Received:	September 8, 2005
Last Updated:	May 5, 2006
ClinicalTrials.gov Identifier:	NCT00198159
Health Authority:	United States: Food and Drug Administration

Keywords provided by Indiana University:

Refractory Germ Cell Tumors

Germ Cell Tumors

Study placed in the following topic categories:

Neoplasms, Germ Cell and Embryonal

Gefitinib

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 21, 2008

Sponsors and Collaborators:	Indiana University School of Medicine AstraZeneca
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00198159