Status:
TERMINATED
Assessing Everolimus in Fist Line Treatment on Patients With Metastatic Kidney Cancer
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (anti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01888042
Start Date
July 1 2011
End Date
July 1 2014
Last Update
February 10 2016
Active Locations (1)
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1
Gustave Roussy
Villejuif, Val de Marne, France, 94805