A Phase II Study of Iressa in Patients With Chemo Refractory Germ Cell Tumors Expressing EGFR
This study has been terminated.
Sponsor:
Indiana University School of Medicine
Collaborator:
AstraZeneca
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00198159
First received: September 8, 2005
Last updated: May 5, 2006
Last verified: September 2005
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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) |
Resource links provided by NLM:
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 |
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00198159 History of Changes |
| Other Study ID Numbers: | 0211-07 |
| Study First Received: | September 8, 2005 |
| Last Updated: | May 5, 2006 |
| Health Authority: | United States: Food and Drug Administration |
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 |
Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013