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

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ClinicalTrials.gov Identifier: NCT00198159
Recruitment Status : Terminated
First Posted : September 20, 2005
Last Update Posted : September 19, 2014
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Indiana University

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.

Condition or disease Intervention/treatment Phase
Refractory Germ Cell Tumors Expressing EGRF Drug: ZD1839 Iressa Phase 2

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  (Clinical Trial)
Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of ZD1839 (Iressa)in Chemotherapy Refractory Germ Cell Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
Study Start Date : September 2002
Actual Primary Completion Date : February 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib
U.S. FDA Resources




Primary Outcome Measures :
  1. To determine the response rate of ZD1839

Secondary Outcome Measures :
  1. To determine duration of response, time to progression and overall survival


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00198159     History of Changes
Other Study ID Numbers: 0211-07
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014

Keywords provided by Indiana University:
Refractory Germ Cell Tumors
Germ Cell Tumors

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action