A Phase IB Clinical Study Of The Farnesyltransferase Inhibitor SCH 66336 And Gemcitabine In Patients With Resectable Primary Liver Neoplasms
OBJECTIVES: I. Determine the biologic activity and toxicity of neoadjuvant SCH 66336 with or
without gemcitabine followed by surgical resection vs surgical resection alone in patients
with resectable primary liver cancer.
OUTLINE: This is a randomized, open-label study. Patients are randomized to one of three
treatment arms. Arm I: Patients receive neoadjuvant oral SCH 66336 twice daily for 14 days
followed by surgical resection. Arm II: Patients receive neoadjuvant oral SCH 66336 twice
daily for 14 days and gemcitabine IV over 30 minutes once weekly for 2 weeks followed by
surgical resection. Arm III: Patients undergo surgical resection. Patients receive no
neoadjuvant therapy prior to resection.
PROJECTED ACCRUAL: Approximately 30 patients (10 per treatment arm) will be accrued for this
Primary Purpose: Treatment
Rafael G. Amado, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration