Phase II Trial of Dovitinib in BCG-Refractory Urothelial Carcinoma Patients with Tumor FGFR3 Mutations or Over-expression: Hoosier Cancer Research Network GU12-157
To determine the 6-month complete response rate in BCG-refractory Urothelial Carcinoma patients treated with dovitinib
Confirmed early stage urothelial carcinoma of the bladder defined as Ta, T1, or Tis stage, Presence of either an FGFR3 mutation or FGFR3 over-expression within bladder tumor tissue, Documented BCG-refractory disease defined as failure to achieve a tumor free state after at least 2 prior induction courses of intravesical BCG therapy, good physical status, good blood/liver/kidney functions, at least 18 years of age, must not have history of significant cardiac disease,must not have uncontrolled hypertension, must not be taking Coumadin, must not have cirrhosis or chronic hepatitis.
Patients will receive Dovitinib 500mg orally once per day on 5 days out of 7, and will be required to come to the clinic for assessment visits 3 times for the first 28-day cycle and for 3 times during the second 28-day cycle; after 2 cycles, visits will be only once at end of cycle. Evaluations will be made every 3 months to assess for response. Patients may stay on the study for up to 6 months or until disease progression; dose modification allowed to 300mg, per reduction criteria.
12/26/2014 04:03 AM