This is a Phase I/II open-label, efficacy and safety study of bicalutamide in combination with sunitinib in patients with advanced renal cell carcinoma (RCC) who have been treated with a receptor tyrosine kinase inhibitor (RTKI) and experienced disease progression.
This is a Phase I/II open-label, efficacy and safety study of bicalutamide in combination with sunitinib in patients with advanced renal cell carcinoma (RCC) who have been treated with a receptor tyrosine kinase inhibitor (RTKI) and experienced disease progression. After entering the study, patients will have sunitinib dosed at the 2 weeks ON and one week OFF scheduled. Dose and schedule modification of sunitinib will be allowed at the discretion of the treating physician. Bicalutamide will be administrated orally at 50 mg daily. This clinical study will utilize the Simon's optimal two stage design. Investigators will enroll 9 patients in the first stage. If no response is seen, then the trial is terminated for futility. Otherwise, accrual continues to a total of 16 patients. If at most 2 patients respond among the 16 patients, this therapy would warrant further investigation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Antineoplastics, Antiandrogen; CYP3A4 Inhibitor
UB/ Great Lakes Cancer Care
Buffalo, New York, United States
RECRUITINGTo assess safety and tolerability of bicalutamide in combination with sunitinib in patients with RTKIs-resistant renal cell carcinoma.
Investigators will report the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: 3 years
To assess efficacy of bicalutamide in combination with sunitinib in patients with RTKIs-resistant renal cell carcinoma.
Investigators will also report the number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging.
Time frame: 3 years
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