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

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ClinicalTrials.gov Identifier: NCT01888042
Recruitment Status : Terminated
First Posted : June 27, 2013
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date February 10, 2016
Study Start Date  ICMJE July 2011
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Overall Survival (OS) [ Time Frame: From inclusion to progression, significant toxicity or death wichever come first up to 56 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • Response rate [ Time Frame: 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 [ Time Frame: From inclusion to progression, significant toxicity or death whichever come first up to 56 months ]
  • Progression Free Survival (PFS) [ Time Frame: From inclusion to progression, significant toxicity or death whichever come first up to 56 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing Everolimus in Fist Line Treatment on Patients With Metastatic Kidney Cancer
Official Title  ICMJE Phase II Study Assessing Everolimus as Fist Line Treatment in Patients With Metastatic Kidney Cancer of Bad Prognosis
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Cancer
Intervention  ICMJE Drug: Everolimus
10 mg (1 tablet of 10 mg)
Study Arms  ICMJE Experimental: Everolimus
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)
Intervention: Drug: Everolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 9, 2016)
61
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
90
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888042
Other Study ID Numbers  ICMJE 2011-00979-14
2011/1733 ( Other Identifier: CSET number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bernard ESCUDIER Gustave Roussy, Cancer Campus, Grand Paris
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP