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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
December 20, 2008
December 23, 2008
November 5, 2014
April 2009
December 2010   (Final data collection date for primary outcome measure)
Objective response rate in the brain after 2 courses [ Time Frame: From beginning of treatment until 2 courses of treatment ]
Objective response rate in the brain after 2 courses
Complete list of historical versions of study NCT00814021 on ClinicalTrials.gov Archive Site
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Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain
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

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Kidney Cancer
  • Metastatic Cancer
Drug: sunitinib malate
Experimental: sunitinib,
Intervention: Drug: sunitinib malate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
March 2011
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00814021
07URO02
ICREGAUD-07URO02
ICREGAUD-Metastases Cerebrales
INCA-RECF0821
PFIZER-ICREGAUD-07URO02
EUDRACT-2008-000948-13
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Institut Claudius Regaud
Institut Claudius Regaud
Not Provided
Study Chair: Christine Chevreau-Dalbianco, MD Institut Claudius Regaud
Institut Claudius Regaud
August 2012

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