Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT00198159
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT00198159
Study Brief:
Protocol Section:
NCT00198159