Clinical trial · Interventional
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)
NCT00198159CI-TRIAL-00015664IUCRO-0021terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Germ Cell Tumors Expressing EGRF | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZD1839 Iressa | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the response rate of ZD1839
Secondary outcomes (1)
- measure
- To determine duration of response, time to progression and overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.