Treatment of germ cell cancer with everolimus
- Conditions
- Germ cell tumor, metastatic, relapsed or refractoryMedDRA version: 17.0Level: PTClassification code 10055103Term: Testicular cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2009-014383-18-DE
- Lead Sponsor
- Medizinische Hochschule Hannover
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
• Male patients >= 18 years old
• Patients with histologically proven seminomatous or non-seminomatous germ cell cancer
• Disease progression during cisplatin-based chemotherapy or Disease progression or relapse after high-dose chemotherapy or Disease progression or relapse after at least 2 different cisplatin-based regimens and contraindications for high-dose chemotherapy
• Patients must have received prior combination chemotherapy with gemcitabine,oxaliplatin and paclitaxel (GOP). Prior treatment with a combination oftwo ofthese drugs is allowed in case of contraindications for GOP.
• Disease progression at study entry: progressive disease according to RECIST criteria in baseline exarninations or tumor marker increase > 25% within 4 weeks before study entry.
• ECOG performance status <= 2
• Life expectancy >=3 months
• Adequate bone marrow function: absolute neutrophil count > 1.5 x 10E9/l, platelets > 75 x 10E9/l, hemoglobin > 9 g/dl.
• Adequate liver function: serum bilirubin: <= 1.5x ULN, ALT and AST <= 2.5x ULN. For
patients with known liver metastases: AST and ALT <= 5x ULN.
• Adequate renal function: serum creatinine <= 2.0x UL .
• Patients must either be surgically sterile or must agree to use effective contraception in the form of either hormonal contraception (implantable, patch) or double-barrier method (any double combination of intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) during study treatment
• Signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
• Systemic anti tumor treatment within 21 days before study entry
• Simultaneous radiotherapy ofthe only target lesion(s)
• Patients who have previously received mTOR inhibitors (sirolimus, temsirolimus,everolimus)
• Patients receiving chronic systemic treatment with corticosteroids (dose of > 20 mg/day
methylprednisone equivalent) or another immunosuppressive agent
• Patients with unstable angina pectoris, myocardial infarction :s 6 months prior to first study treatment, congestive heart failure NYHA IH-IV or serious uncontrolled cardiac arrhythmias
• Patients with severely impaired lung function: spirometry or DLCO < 50% ofthe normal predicted value
• Uncontrolled diabetes: fasting serum glucose> 2.0x ULN.
• Patients with an active or uncontrolled infection, including chronic Hepatitis B or C.
• Patients who have a history of another primary malignancy and are off treatment for <= 3 years, with the exception of non-melanoma skin cancer
• Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traurnatic injury, or who have not recovered from the side effects of any of the above
• Patients who have participated in another clinical trial within 30 days before study entry
• Other serious medical conditions that could impair the ability of the patient to participate in the study
• Patients unwilling or unable to comply with the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method