Colorectal Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.
PURPOSE: Randomized phase I trial to compare the effectiveness of different doses of SCH
66336 before surgery in treating patients who have colorectal cancer that has metastasized to
the liver.
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
10 months.
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