Phase II Study of Everolimus in Refractory Testicular Germ Cell Cancer.
Inclusion Criteria:
1. Signed written informed consent
2. Men aged 18 years or older
3. ECOG performance status: 0-2,
4. Histological confirmed extracranial primary germ cell cancer, seminoma, or
nonseminoma
5. Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on
sequential measurement or biopsy-proven unresectable germ cell cancer
6. Refractory GCTs e.g. patients relapsing after high-dose chemotherapy or for patients
non fit enough for high-dose chemotherapy
7. Primary mediastinal GCTs in first relapse
8. Patient's disease must not be amenable to cure with either surgery or chemotherapy in
the opinion of investigator,
9. Measurable disease radiological
10. Adequate hematologic function defined by WBC > 4000/mm3, platelet count > 100
000/mm3 and hemoglobin level > 9g/dl.
11. Adequate liver function defined by a total bilirubin level < 1.5 ULN, and ALT, AST <
2,5 ULN and adequate renal function defined by serum creatinine ≤ 1.5 x ULN.
12. At least 2 weeks must have elapsed since the last radiotherapy and/or chemotherapy
before study entry,
13. At least 4 weeks must have elapsed since the last major surgery
14. Complete recovery from prior surgery, and/or reduction of all adverse events from
previous systemic therapy or radiotherapy to grade 1,
15. Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule, -
Exclusion Criteria:
1. Patients who do not fit inclusion criteria,
2. Other prior malignancy except successfully treated non melanoma skin cancer
3. Prior treatment with mTOR inhibitor
4. No other concurrent approved or investigational anticancer treatment, including
surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or
immunotherapy
5. Female patients,
6. Patients infected by the Human Immunodeficiency Virus (HIV),
7. Patients with other severe acute or chronic medical condition, or laboratory
abnormality that would impair, in the judgment of investigator, excess risk
associated with study treatment, or which, in judgment of the investigator, would
make the patient inappropriate for entry into this study,
8. Inability of oral intake, or drug absorption (e.g. malabsorption syndrome)
9. Hypersensitivity to any compound of the drug,
10. Sexually active men not using effective birth control if their partners are women of
child-bearing potential.
11. Patients with active CNS metastasis