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

Inclusion 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