Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
RATIONALE: Sorafenib 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 sorafenib works in treating patients with metastatic kidney cancer that has not responded to sunitinib or bevacizumab.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma with a component of clear cell histology
Disease progression, as defined by RECIST criteria, after prior treatment with sunitinib malate or bevacizumab
Measurable disease by RECIST criteria
CNS metastases allowed provided patient has undergone prior surgery and/or radiotherapy AND has no evidence of further CNS disease progression by CT scan or MRI ≥ 2 weeks after treatment of CNS metastases
PATIENT CHARACTERISTICS:
ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
WBC ≥ 3,000/μL
Absolute neutrophil count ≥ 1,500/μL
Platelet count ≥ 75,000/μL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST/ALT ≤ 2.5 times ULN
Creatinine ≤ 2.0 times ULN
Negative pregnancy test
No significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
Masking
49 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal