Phase II Study Assessing Everolimus as Fist Line Treatment in Patients With Metstatic Kidney Cancer of Bad Prognosis
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer
Both
Kidney Cancer
Trial Information
Phase II Study Assessing Everolimus as Fist Line Treatment in Patients With Metstatic Kidney Cancer of Bad Prognosis
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:
- Karnofski <80
- LDH> 1.5 ULN
- hemoglobin
- 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
opotherap.. 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 angor, 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival (OS)
Outcome Time Frame:
From inclusion to progression, significant toxicity or death wichever come first up to 56 months
Safety Issue:
Yes
Principal Investigator
Bernard ESCUDIER
Investigator Role:
Study Chair
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
2011-00979-14
NCT ID:
NCT01888042
Start Date:
July 2011
Completion Date:
January 2019
Related Keywords:
- Kidney Cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
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