Assessing Everolimus in Fist Line Treatment on Patients With Metastatic Kidney Cancer

Study Overview
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Brief Summary
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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

Official Title
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Phase II Study Assessing Everolimus as Fist Line Treatment in Patients With Metastatic Kidney Cancer of Bad Prognosis

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: Everolimus


Participation Criteria
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Eligibility Criteria
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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: Karnofsky <80 LDH> 1.5 ULN hemoglobin <LLN corrected calcium> 2.5 mmol / l (10 mg / dl) Time frame between initial diagnostic and treatment <1 year More than one metastatic site 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: unstable angina, symptomatic heart failure, myocardial infarction ≤ 6 months before randomization, severe rhythm disorder, Uncontrolled diabetes with glycaemia> 1.5X ULN. Active or uncontrolled infection. cirrhosis or chronic active hepatitis, severe alteration in lung function (> 50% decrease in FEV or vital capacity) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Everolimus<br>Everolimus will be administered per os every day at the same hour immediately after a meal with a glass of water 10 mg (1 tablet of 10 mg) | Drug: Everolimus<br>* 10 mg (1 tablet of 10 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | From inclusion to progression, significant toxicity or death wichever come first up to 56 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response rate based on RECIST 1.1 criteria | From inclusion to progression, significant toxicity or death whichever come first up to 56 months | 
| Toxicity of Everolimus |  | From inclusion to progression, significant toxicity or death whichever come first up to 56 months | 
| Progression Free Survival (PFS) |  | From inclusion to progression, significant toxicity or death whichever come first up to 56 months |