Everolimus in Refractory Testicular Germ Cell Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Germ Cell Tumor
• Intervention / Treatment: Drug: Everolimus

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Slovakia
  • Bratislava, Slovakia, 83310
    • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: everolimus 10 mg po daily	Drug: Everolimus; Tablets p.o. 10 mg daily until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.; Other Names: Afinitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	according RECIST criteria version 1.1	36 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Favorable response rate	complete response with chemotherapy and/or surgery, partial response marker negative.	36 month
Clinical benefit rate	(complete and partial response and stable disease > 6 months)	36 month
Progression-free survival	expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate	36 month
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	>90% decline of AFP and/or HCG	36 month

Collaborators and Investigators

• Sponsor: National Cancer Institute, Slovakia
• Investigators: Principal Investigator: Jozef Mardiak, Prof, National Cancer Institute (NCI); Study Chair: Michal Mego, Ass.prof., National Cancer Institute, Slovakia

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: November 4, 2011
• First Posted (ESTIMATE): November 6, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: everolimus; refractory germ cell cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: GCTSK002