Everolimus in Refractory Testicular Germ Cell Cancer

Germ Cell Tumor Clinical Trial

Official title:

Phase II Study of Everolimus in Refractory Testicular Germ Cell Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466231
• Other study ID #: GCTSK002
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2011
• Last updated: January 11, 2016
• Start date: November 2011
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: National Cancer Institute, Slovakia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Germ Cell Tumor
• Testicular Neoplasms

Intervention

Drug:
• Everolimus
Tablets p.o. 10 mg daily until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.

Locations

Country	Name	City	State
Slovakia	National Cancer Institute	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Slovakia

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	according RECIST criteria version 1.1	36 month	No
Secondary	Favorable response rate	complete response with chemotherapy and/or surgery, partial response marker negative.	36 month	No
Secondary	Clinical benefit rate	(complete and partial response and stable disease > 6 months)	36 month	No
Secondary	Progression-free survival	expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate	36 month	No
Secondary	Toxicity		36 month	Yes
Secondary	Frequency of grade III and IV adverse events		36 month	Yes
Secondary	Association between clinical outcome and biomarkers		36 month	No
Secondary	Serum tumor markers response	>90% decline of AFP and/or HCG	36 month	No