Kidney CancerPhase 2NCT00814021
Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain
A Phase 2 study testing sunitinib malate in people with Kidney Cancer and Metastatic Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Kidney Cancer, Metastatic Cancer
- What is being tested?
- sunitinib malate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Kidney Cancer, Metastatic Cancer
- Being tested
- sunitinib malate
- Keywords
- recurrent renal cell cancer, stage IV renal cell cancer, tumors metastatic to brain
- Medical subject headings
- Kidney Neoplasms, Neoplasm Metastasis, Carcinoma, Renal Cell, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib malateDrug
| Study group | Role | What they receive |
|---|---|---|
| sunitinib, | Experimental | Not described Receives: Drug: sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate in the brain after 2 courses
Measured: From beginning of treatment until 2 courses of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Chevreau-Dalbianco, MD, Study chair, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814021
- Sponsor's protocol ID
- 07URO02
- Other IDs
- ICREGAUD-07URO02, ICREGAUD-Metastases Cerebrales, INCA-RECF0821, PFIZER-ICREGAUD-07URO02, EUDRACT-2008-000948-13
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2008
- Last updated
- 15 Apr 2026
- Results posted
- No
Publications
Chevreau C, Ravaud A, Escudier B, Amela E, Delva R, Rolland F, Tosi D, Oudard S, Blanc E, Ferlay C, Negrier S; French Group on Renal Cancer. A phase II trial of sunitinib in patients with renal cell cancer and untreated brain metastases. Clin Genitourin Cancer. 2014 Feb;12(1):50-4. doi: 10.1016/j.clgc.2013.09.008. Epub 2013 Sep 28.
PubMed 24268852
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00814021
- Acronym / sponsor ID
- 07URO02
- Conditions
- Kidney Cancer, Metastatic Cancer
- Keywords
- recurrent renal cell cancer, stage IV renal cell cancer, tumors metastatic to brain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sunitinib, | Experimental | Drug: sunitinib malate |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sunitinib malate | Drug | sunitinib, |
Primary outcome
Objective response rate in the brain after 2 courses
Time frame: From beginning of treatment until 2 courses of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Results publication: PubMed 24268852Chevreau C, Ravaud A, Escudier B, Amela E, Delva R, Rolland F, Tosi D, Oudard S, Blanc E, Ferlay C, Negrier S; French Group on Renal Cancer. A phase II trial of sunitinib in patients with renal cell cancer and untreated brain metastases. Clin Genitourin Cancer. 2014 Feb;12(1):50-4. doi: 10.1016/j.clgc.2013.09.008. Epub 2013 Sep 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Chevreau-Dalbianco, MD study chair
Institut Claudius Regaud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sunitinib malate in people with Kidney Cancer and Metastatic Cancer, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate in the brain after 2 courses (time frame: From beginning of treatment until 2 courses of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00814021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.