Status:
UNKNOWN
Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma
Lead Sponsor:
Yamagata University
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to improve progression free ...
Eligibility Criteria
Inclusion
- 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:
- Respiratory function: %VC, 80% and FEV1.0,70%
- Hematology: white blood cell count4,000/mm3, platelet count100,000/mm3
- Clinical chemistry: GOT and GPT within the normal range of each medical institution; total bilirubin \<1.5 x ULN
- Serum creatinin \<2.0mg/dl, blood urea nitrogen (BUN) \<25mg/dl
- Echocardiographic estimation of left ventricular ejection fraction is higher than the lower limit of reference range of each medical institution.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01481870
Start Date
January 1 2010
End Date
December 1 2015
Last Update
February 25 2013
Active Locations (1)
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1
Yamagata University Faculty of Medicine
Yamagata, Japan, 990-9585