Status:
COMPLETED
Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Kidney Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 we...
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 can...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00814021
Start Date
April 1 2009
End Date
March 1 2011
Last Update
November 5 2014
Active Locations (1)
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1
Institut Claudius Regaud
Toulouse, France, 31052