A Phase II Study of Iressa in Patients With Chemo Refractory Germ Cell Tumors Expressing EGFR (IUCRO-0021)

September 18, 2014 updated by: Indiana University School of Medicine

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the response rate of ZD1839

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Lawrence Einhorn, M, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0211-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Refractory Germ Cell Tumors Expressing EGRF

Clinical Trials on ZD1839 Iressa

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe