Everolimus in Refractory Testicular Germ Cell Cancer

Phase 2

Completed

• Conditions: Germ Cell Tumor
• Interventions: Drug: Everolimus

• Registration Number: NCT01466231
• Lead Sponsor: National Cancer Institute, Slovakia

Brief Summary

Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.

Detailed Description

Treatment Schedule: Everolimus will be administered at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days.

Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.

Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.

Study Timeline

• Study First Submitted: 2011-10-31
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
everolimus 10 mg po daily	Everolimus	everolimus 10 mg po daily

Primary Outcome Measures

Name	Time	Method
Response rate	36 month	according RECIST criteria version 1.1

Secondary Outcome Measures

Name	Time	Method
Favorable response rate	36 month	complete response with chemotherapy and/or surgery, partial response marker negative.
Clinical benefit rate	36 month	(complete and partial response and stable disease \> 6 months)
Progression-free survival	36 month	expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate
Toxicity	36 month
Frequency of grade III and IV adverse events	36 month
Association between clinical outcome and biomarkers	36 month
Serum tumor markers response	36 month	\>90% decline of AFP and/or HCG

Trial Locations

Locations (1)

National Cancer Institute; 🇸🇰 Bratislava, Slovakia