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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

September 8, 2005
September 20, 2005
September 19, 2014
September 2002
February 2006   (Final data collection date for primary outcome measure)
To determine the response rate of ZD1839
Same as current
Complete list of historical versions of study NCT00198159 on ClinicalTrials.gov Archive Site
To determine duration of response, time to progression and overall survival
Same as current
Not Provided
Not Provided
 
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)
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.
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Refractory Germ Cell Tumors Expressing EGRF
Drug: ZD1839 Iressa
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
Same as current
March 2006
February 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00198159
0211-07
Not Provided
Not Provided
Not Provided
Not Provided
Indiana University School of Medicine
AstraZeneca
Principal Investigator: Lawrence Einhorn, M Indiana University
Indiana University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP