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

NCT00198159 | Terminated Phase 2

• 1 other identifier: 0211-07
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Germ Cell Tumors Expressing EGRF

Keywords

Refractory Germ Cell Tumors; Germ Cell Tumors

Outcome Measures

Primary Outcomes (1)

• To determine the response rate of ZD1839

Secondary Outcomes (1)

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

Interventions

ZD1839 Iressa DRUG

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• AstraZeneca: collaborator

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lawrence Einhorn, M

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2002
• Primary Completion: February 1, 2006
• Study Completion: March 1, 2006
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

US (1)