Kidney Cancer, Metastatic Cancer
Conditions
Keywords
recurrent renal cell cancer, stage IV renal cell cancer, tumors metastatic to brain
Brief 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.
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.
Interventions
DRUGsunitinib malate
Sponsors
Institut Claudius Regaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate in the brain after 2 courses | From beginning of treatment until 2 courses of treatment |
Countries
France
Contacts
STUDY_CHAIRChristine Chevreau-Dalbianco, MD
Institut Claudius Regaud
Outcome results
None listed