Spots Global Cancer Trial Database for SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver

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Trial Identification

Brief Title: SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver

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 ID: NCT00005030

Conditions

Colorectal Cancer

Metastatic Cancer

Interventions

SCH 66336

conventional surgery

Study Description

Brief Summary: 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.

Detailed Description: 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.