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

This study is currently recruiting participants.
Verified June 2013 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01888042
First received: June 25, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

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.

90 patients will be included (anticipated). The treatment by everolimus will continue until progression, significant toxicity or withdraw of consent


Condition Intervention Phase
Kidney Cancer
Drug: Everolimus
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Assessing Everolimus as Fist Line Treatment in Patients With Metstatic Kidney Cancer of Bad Prognosis

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From inclusion to progression, significant toxicity or death wichever come first up to 56 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: From inclusion to progression, significant toxicity or death whichever come first up to 56 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Progression Free Survival (PFS) [ Time Frame: From inclusion to progression, significant toxicity or death whichever come first up to 56 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2011
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus
Everolimus will be administred per os every day at the same hour immediatly after a meal with a glass of water 10 mg (1 tablet of 10 mg)
Drug: Everolimus
10 mg (1 tablet of 10 mg)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

    • Karnofski <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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01888042

Contacts
Contact: Bernard ESCUDIER, MD 0142115410 ext +33 bernard.escudier@gustaveroussy.fr
Contact: Valérie MAIROT 0142116643 ext +33 valerie.mairot@gustaveroussy.fr

Locations
France
Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Bernard ESCUDIER, MD    0142445410 ext +33    bernard.escudier@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Study Chair: Bernard ESCUDIER Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01888042     History of Changes
Other Study ID Numbers: 2011-00979-14, 2011/1733
Study First Received: June 25, 2013
Last Updated: June 25, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on April 23, 2014