A Phase IB Study of Oral Administration of SCH 66336 Preoperatively in Patients With Colorectal Carcinoma Metastatic to the Liver Scheduled for Exploratory Laparotomy and/or Resection
OBJECTIVES: I. Determine the biologic activity and safety of preoperative SCH 66336 in
patients with colorectal carcinoma metastatic to the liver.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four
doses of preoperative SCH 66336 (no treatment, 100 mg, 200 mg, or 300 mg). Patients receive
oral SCH 66336 twice daily for 7-14 days prior to exploratory laparotomy and/or resection of
hepatic metastases. Patients randomized to no treatment may undergo surgery at any time
within 15 days of randomization. Other patients undergo surgery on days 8-15.
PROJECTED ACCRUAL: A total of 40 patients (10 per arm) will be accrued for this study within
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Steven A. Curley, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board