SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver
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.
Drug: SCH 66336
Procedure: conventional surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
|Study Start Date:||June 2000|
|Study Completion Date:||September 2000|
|Primary Completion Date:||September 2000 (Final data collection date for primary outcome measure)|
Experimental: SCH 66336
Starting dose of preoperative oral SCH 66336 100 mg twice daily for 7-14 days prior to exploratory laparotomy and/or resection of hepatic metastases with surgery between days 8-15.
Drug: SCH 66336
Other Name: lonafarnibProcedure: conventional surgery
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.
No Intervention: No Treatment
Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005030
|Study Chair:||Steven A. Curley, MD||M.D. Anderson Cancer Center|