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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00814021
First received: December 20, 2008
Last updated: November 4, 2014
Last verified: August 2012
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

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
Study First Received: December 20, 2008
Last Updated: November 4, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

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

ClinicalTrials.gov processed this record on November 20, 2014