Clinical trial NCT00814021: Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Metastatic Cancer
Keywords: recurrent renal cell cancer
stage IV renal cell cancer
tumors metastatic to brain
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Objective response rate in the brain after 2 courses
timeFrame: From beginning of treatment until 2 courses of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Institut Claudius Regaud
name: Christine Chevreau-Dalbianco, MD
role: STUDY_CHAIR
References: