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

Kidney Cancer Clinical Trial

— POORTOR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01888042
• Other study ID #: 2011-00979-14
• Secondary ID: 2011/1733
• Status: Terminated
• Phase: Phase 2
• First received: June 25, 2013
• Last updated: February 9, 2016
• Start date: July 2011
• Est. completion date: July 2014

Study information

• Verified date: February 2016
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• Everolimus
10 mg (1 tablet of 10 mg)

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val de Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		From inclusion to progression, significant toxicity or death wichever come first up to 56 months	Yes
Secondary	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	No
Secondary	Toxicity of Everolimus		From inclusion to progression, significant toxicity or death whichever come first up to 56 months	Yes
Secondary	Progression Free Survival (PFS)		From inclusion to progression, significant toxicity or death whichever come first up to 56 months	No