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About
It is a an open label, multicentric, phase II study assessing the efficacy of everolimus (given per os) as a first line treatment in kidney cancer of bad prognosis.
92 patients will be included (anticipated). The treatment by everolimus will continue until progression, significant toxicity or withdraw of consent
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Metastatic kidney cancer, regardless of histology (except Bellini carcinomas), with measurable or evaluable disease
Age >= 18 years
With Karnofsky ≥ 60
Without prior treatment for metastatic cancer (chemotherapy, targeted therapy, or mTOR inhibitor)
Bad prognosis, defined as follows: at least three of the following six criteria of poor prognosis:
medullary function: neutrophils ≥ 1.5 x 109 / L, Platelets ≥ 100 x 109 / L, Hb> 8g/dL
Hepatic function: bilirubin: ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN in the absence of hepatic metastasis ≤ 5x ULN if hepatic metastasis documented
Renal function: creatinine <1.5 x ULN
Life expectancy> 3 months,
Patient signed informed consent and agreeing to comply with the requirements of the trial
Exclusion criteria
Previous treatment with chemotherapy, targeted therapy, or mTOR inhibitor
Previous radiotherapy in the last 2 weeks
Chronic treatment with corticoids or immunosuppressive agents except substitutive opotherapy.. A washout period of at least 8 days must be respected before the patient inclusion.
Patients with brain metastases untreated or uncontrolled by prior treatment. The non-progression of the metastases must be proved by comparing two brain scans separated by a minimum interval of 6 weeks.
Active bleeding
Patient with positive serology HBs (Ag HBs (+) and AC anti-HBc (+)
Hypersensitivity to everolimus, sirolimus, to other rapamycin derivatives or to any of the excipients
Severe or uncontrolled medical pathology:
Other cancer within the past 3 years, with the exception of basal cell carcinoma and carcinoma in situ of the cervix
Pregnant or lactating woman, and adults refusing an effective contraceptive method
Participation in another clinical trial with an investigational drug
Refusal of the patient to comply with the rules of the clinical trial
Person deprived of liberty or person under guardianship, inability to submit to medical treatment test for geographical, social or psychological reasons.
Primary purpose
Allocation
Interventional model
Masking
61 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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