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Everolimus in Refractory Testicular Germ Cell Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01466231
First Posted: November 7, 2011
Last Update Posted: January 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute, Slovakia
  Purpose
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.

Condition Intervention Phase
Germ Cell Tumor Drug: Everolimus Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Everolimus in Refractory Testicular Germ Cell Cancer.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Slovakia:

Primary Outcome Measures:
  • Response rate [ Time Frame: 36 month ]
    according RECIST criteria version 1.1


Secondary Outcome Measures:
  • Favorable response rate [ Time Frame: 36 month ]
    complete response with chemotherapy and/or surgery, partial response marker negative.

  • Clinical benefit rate [ Time Frame: 36 month ]
    (complete and partial response and stable disease > 6 months)

  • Progression-free survival [ Time Frame: 36 month ]
    expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate

  • Toxicity [ Time Frame: 36 month ]
  • Frequency of grade III and IV adverse events [ Time Frame: 36 month ]
  • Association between clinical outcome and biomarkers [ Time Frame: 36 month ]
  • Serum tumor markers response [ Time Frame: 36 month ]
    >90% decline of AFP and/or HCG


Enrollment: 15
Study Start Date: November 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: everolimus 10 mg po daily
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 Name: Afinitor

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466231


Locations
Slovakia
National Cancer Institute
Bratislava, Slovakia, 83310
Sponsors and Collaborators
National Cancer Institute, Slovakia
Investigators
Principal Investigator: Jozef Mardiak, Prof National Cancer Institute (NCI)
Study Chair: Michal Mego, Ass.prof. National Cancer Institute, Slovakia
  More Information

Responsible Party: National Cancer Institute, Slovakia
ClinicalTrials.gov Identifier: NCT01466231     History of Changes
Other Study ID Numbers: GCTSK002
First Submitted: October 31, 2011
First Posted: November 7, 2011
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by National Cancer Institute, Slovakia:
refractory germ cell cancer
everolimus

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents


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