Everolimus in Refractory Testicular Germ Cell Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Slovakia
ClinicalTrials.gov Identifier:
NCT01466231
First received: October 31, 2011
Last updated: January 11, 2016
Last verified: January 2016
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    according RECIST criteria version 1.1


Secondary Outcome Measures:
  • Favorable response rate [ Time Frame: 36 month ] [ Designated as safety issue: No ]
    complete response with chemotherapy and/or surgery, partial response marker negative.

  • Clinical benefit rate [ Time Frame: 36 month ] [ Designated as safety issue: No ]
    (complete and partial response and stable disease > 6 months)

  • Progression-free survival [ Time Frame: 36 month ] [ Designated as safety issue: No ]
    expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate

  • Toxicity [ Time Frame: 36 month ] [ Designated as safety issue: Yes ]
  • Frequency of grade III and IV adverse events [ Time Frame: 36 month ] [ Designated as safety issue: Yes ]
  • Association between clinical outcome and biomarkers [ Time Frame: 36 month ] [ Designated as safety issue: No ]
  • Serum tumor markers response [ Time Frame: 36 month ] [ Designated as safety issue: No ]
    >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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: October 31, 2011
Last Updated: January 11, 2016
Health Authority: Slovakia: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on July 27, 2016