Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma
Inclusion Criteria:
- Age: 20-80 years old, both inclusive
- ECOG performance status of 0, 1, or 2
- MSKCC risk of favorable or intermediate
- Histologically confirmed renal cell carcinoma
- No ischemic heart disease
- Laboratory findings meet the following criteria:
1. Respiratory function: %VC, 80% and FEV1.0,70%
2. Hematology: white blood cell count4,000/mm3, platelet count100,000/mm3
3. Clinical chemistry: GOT and GPT within the normal range of each medical
institution; total bilirubin <1.5 x ULN
4. Serum creatinin <2.0mg/dl, blood urea nitrogen (BUN) <25mg/dl
5. Echocardiographic estimation of left ventricular ejection fraction is higher
than the lower limit of reference range of each medical institution.
Exclusion Criteria:
- History of any other malignancy
- Central nervous system metastases. However, patients who remain asymptomatic, have no
new or enlarging lesion in the CNS within 6 months of enrollment in this study, and
require no corticosteroids may be enrolled.
- History of cardiac infarction, unstable angina, congestive heart failure, or
symptomatic peripheral vascular disease within 12 months of enrollment
- History of cerebrovascular disorder including transient ischemic attack (TIA)
- Pregnancy or possible pregnancy at any time during the study
- Ongoing grade 2 adverse event prior treatment
- Prior treatment with any anticancer therapy including cytokine therapy such as
interferon-alpha and interleukin-2
- Prior treatment with mTOR inhibitor
- Prior treatment with sunitinib or sorafenib
- Treatment with an test drug in a clinical research within 4 weeks of enrollment in
this study