Refractory Germ Cell Tumors Expressing EGRFPhase 2IUCRO-0021NCT00198159
A Phase II Study of Iressa in Patients With Chemo Refractory Germ Cell Tumors Expressing EGFR
A Phase 2 study testing ZD1839 Iressa in people with Refractory Germ Cell Tumors Expressing EGRF, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Refractory Germ Cell Tumors Expressing EGRF
- What is being tested?
- ZD1839 Iressa
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Mar 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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.
- Being tested
- ZD1839 Iressa
- Keywords
- Refractory Germ Cell Tumors, Germ Cell Tumors
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD1839 IressaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the response rate of ZD1839
Secondary outcomes (1)
To determine duration of response, time to progression and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionFeb 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Germ Cell Tumors Expressing EGRFStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Lawrence Einhorn, M, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198159
- Sponsor's protocol ID
- 0211-07
- Acronym
- IUCRO-0021
- Status last verified
- Sep 2014
- First submitted
- 8 Sep 2005
- Last updated
- 19 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of ZD1839 (Iressa)in Chemotherapy Refractory Germ Cell Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
- ClinicalTrials.gov ID
- NCT00198159
- Acronym / sponsor ID
- IUCRO-0021 / 0211-07
- Keywords
- Refractory Germ Cell Tumors, Germ Cell Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 21 participants
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Sep 2002
- Primary completion
- Feb 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZD1839 Iressa | Drug | – |
Primary outcome
To determine the response rate of ZD1839
1 secondary outcome
To determine duration of response, time to progression and overall survival
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Einhorn, M principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZD1839 Iressa in people with Refractory Germ Cell Tumors Expressing EGRF, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the response rate of ZD1839. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.