renal cell cancer
Conditions
Interventions
sunitinib administration, washout period, sorafenib administration
sorafenib administration, washout period, sunitinib administration
Sponsors
Yamagata University Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: 20-80 years old, both inclusive 2) ECOG performance status of 0, 1, or 2 3) MSKCC risk of favorable or intermediate 4) Histologically confirmed renal cell carcinoma 5) No ischemic heart disease 6) 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
Exclusion criteria: 1) History of any other malignancy 2) 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. 3) History of cardiac infarction, unstable angina, congestive heart failure, or symptomatic peripheral vascular disease within 12 months of enrollment 4) History of cerebrovascular disorder including transient ischemic attack (TIA) 5) Pregnancy or possible pregnancy at any time during the study 6) Ongoing grade 2 adverse event prior treatment 7) Prior treatment with any anticancer therapy including cytokine therapy such as interferon-alpha and interleukin-2 8) Prior treatment with mTOR inhibitor 9) Prior treatment with sunitinib or sorafenib 10) Treatment with an test drug in a clinical research within 4 weeks of enrollment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS in first-line treatment, Total progression free survival (PFS) in first-line and second-line treatments | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS in second-line treatment, Antitumor effect, survival, clinical benefit (CR+PR+NC), and adverse event | — |
Countries
Japan
Contacts
Public ContactYoshihiko Tomita
Yamagata University Faculty of Medicine, Department of Urology
Outcome results
None listed