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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

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


Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: Everolimus Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Assessing Everolimus as Fist Line Treatment in Patients With Metastatic Kidney Cancer of Bad Prognosis
Study Start Date : July 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources

Arm Intervention/treatment
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)
Drug: Everolimus
10 mg (1 tablet of 10 mg)



Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From inclusion to progression, significant toxicity or death wichever come first up to 56 months ]

Secondary Outcome Measures :
  1. 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

  2. Toxicity of Everolimus [ Time Frame: From inclusion to progression, significant toxicity or death whichever come first up to 56 months ]
  3. Progression Free Survival (PFS) [ Time Frame: From inclusion to progression, significant toxicity or death whichever come first up to 56 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888042


Locations
France
Gustave Roussy
Villejuif, Val de Marne, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Study Chair: Bernard ESCUDIER Gustave Roussy, Cancer Campus, Grand Paris

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01888042     History of Changes
Other Study ID Numbers: 2011-00979-14
2011/1733 ( Other Identifier: CSET number )
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents