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Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00814021
First Posted: December 23, 2008
Last Update Posted: November 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut Claudius Regaud
  Purpose

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with kidney cancer that has spread to the brain.


Condition Intervention Phase
Kidney Cancer Metastatic Cancer Drug: sunitinib malate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study, Multicenter, Open-label, Evaluating Efficacy of Treatment With Sutent® (Sunitinib) in Patients With Previously Untreated or Recurrent Brain Metastases Originating From Renal Cancer

Resource links provided by NLM:


Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • Objective response rate in the brain after 2 courses [ Time Frame: From beginning of treatment until 2 courses of treatment ]

Enrollment: 21
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sunitinib, Drug: sunitinib malate

Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate in the brain after 2 courses of sunitnib malate in patients with previously untreated or recurrent brain metastases secondary to renal cancer following radiotherapy or surgery.

Secondary

  • Evaluate duration of response.
  • Evaluate objective response of non-CNS targets.
  • Evaluate time to disease progression.
  • Evaluate overall and progression-free survival.
  • Evaluate neurological symptoms associated with the tumor.
  • Evaluate feasibility and overall tolerance of this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the kidney

    • Metastatic disease
  • Measurable disease by RECIST criteria
  • Presence of previously untreated or recurrent brain metastases following radiotherapy or surgery

    • No brain metastasis revealed by hemorrhage
    • No single brain metastasis < 2 cm that is accessible by surgery or radiosurgery

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2 (unless paresis due to brain metastases)
  • ANC > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 8 g/dL
  • PT or INR < 1.5 times upper limit of normal (ULN)
  • AST/ALT < 2.5 times ULN (< 5 times ULN in the case of liver metastases)
  • Total bilirubin < 1.5 times ULN
  • Serum creatinine < 200 μmol/L
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for up to 30 days following completion of study treatment
  • No other cancer except for in situ cervical cancer, curatively treated basal cell carcinoma of the skin, or other curatively treated cancer without evidence of recurrence within the past 5 years
  • No uncontrolled hypertension (systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 90 mm Hg)
  • None of the following cardiac conditions within the past 6 months:

    • Significant cardiovascular disease
    • NYHA class III-IV congestive heart failure
    • Myocardial infarction
    • Unstable angina
    • Severe arrhythmia
    • Cerebrovascular accident
    • Severe thromboembolism
  • No serious neuropsychiatric disease
  • No psychological, familial, social, or geographic situations that preclude clinical follow-up
  • No patient deprived of liberty by a court or administrative order
  • Able to understand French

PRIOR CONCURRENT THERAPY:

  • At least 6 months since prior antineoplastic treatment with sunitinib malate
  • At least 4 weeks since other prior treatment
  • At least 3 weeks since prior hematopoietic growth factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF])
  • No concurrent antivitamin K at curative or anticoagulation doses
  Contacts and Locations
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): NCT00814021


Locations
France
Institut Claudius Regaud
Toulouse, France, 31052
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Study Chair: Christine Chevreau-Dalbianco, MD Institut Claudius Regaud
  More Information

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT00814021     History of Changes
Other Study ID Numbers: 07URO02
ICREGAUD-07URO02
ICREGAUD-Metastases Cerebrales
INCA-RECF0821
PFIZER-ICREGAUD-07URO02
EUDRACT-2008-000948-13
First Submitted: December 20, 2008
First Posted: December 23, 2008
Last Update Posted: November 5, 2014
Last Verified: August 2012

Keywords provided by Institut Claudius Regaud:
recurrent renal cell cancer
stage IV renal cell cancer
tumors metastatic to brain

Additional relevant MeSH terms:
Neoplasm Metastasis
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplastic Processes
Neoplasms
Pathologic Processes
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors