Kidney Cancer
Conditions
Brief summary
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
Interventions
DRUGEverolimus
10 mg (1 tablet of 10 mg)
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Metastatic kidney cancer, regardless of histology (except Bellini carcinomas), with measurable or evaluable disease 2. Age \>= 18 years 3. With Karnofsky ≥ 60 4. Without prior treatment for metastatic cancer (chemotherapy, targeted therapy, or mTOR inhibitor) 5. 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 6. medullary function: neutrophils ≥ 1.5 x 109 / L, Platelets ≥ 100 x 109 / L, Hb\> 8g/dL 7. 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 8. Renal function: creatinine \<1.5 x ULN 9. Life expectancy\> 3 months, 10. Patient signed informed consent and agreeing to comply with the requirements of the trial
Exclusion criteria
1. Previous treatment with chemotherapy, targeted therapy, or mTOR inhibitor 2. Previous radiotherapy in the last 2 weeks 3. 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. 4. 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. 5. Active bleeding 6. Patient with positive serology HBs (Ag HBs (+) and AC anti-HBc (+) 7. Hypersensitivity to everolimus, sirolimus, to other rapamycin derivatives or to any of the excipients 8. 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) 9. Other cancer within the past 3 years, with the exception of basal cell carcinoma and carcinoma in situ of the cervix 10. Pregnant or lactating woman, and adults refusing an effective contraceptive method 11. Participation in another clinical trial with an investigational drug 12. Refusal of the patient to comply with the rules of the clinical trial 13. Person deprived of liberty or person under guardianship, inability to submit to medical treatment test for geographical, social or psychological reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | From inclusion to progression, significant toxicity or death wichever come first up to 56 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | From inclusion to progression, significant toxicity or death whichever come first up to 56 months | Response rate based on RECIST 1.1 criteria |
| 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 | — |
Countries
France
Outcome results
None listed