refractory metastatic germ cell tumors
Conditions
Interventions
Trade Name: Afinitor
Product Name: Afinitor
Product Code: L01XE10
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
National Cancer Institute
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent 2. Men aged 18 years or older 3. ECOG performance status: 0-2, 4. Histologically 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 radiologically 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who do not fit inclusion criteria 2. Other prior malignancy except successfully treated nonmelanoma skin cancer 3. Prior treatment with mTOR inhibitor 4. 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 sever 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 absorbtion (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy (as measured by response rate) of Everolimus in patients with refractory germ cell tumors (GCTs).;Secondary Objective: To describe the favourable response rate, time to progression and toxic effects of Everolimus in patients with refractory metastatic germ cell cancer. ;Primary end point(s): Response rate (according RECIST criteria version 1.1) (intent-to-treat population);Timepoint(s) of evaluation of this end point: Recruitment Start Date (FPI): 07/11 (recruitment duration: 24 months, expected median treatment duration: 3 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Favourable response rate = complete response with chemotherapy and/or surgery, partial response marker negative. • Clinical benefit rate (complete and partial response and stable disease > 6 months) • Serum tumor markers response (>90% decline of AFP and/or HCG) • Progression-free survival expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate • Toxicity • Frequency of grade III and IV adverse events • Association between clinical outcome and biomarkers ;Timepoint(s) of evaluation of this end point: Recruitment Start Date (FPI): 07/11 (recruitment duration: 24 months, expected median treatment duration: 3 months) | — |
Countries
Slovakia
Contacts
Public ContactNCI
National Cancer Institute
Outcome results
None listed