Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma|
- Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine. [ Time Frame: Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2000|
|Study Completion Date:||November 2003|
|Primary Completion Date:||November 2003 (Final data collection date for primary outcome measure)|
- Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
- Evaluate tumor tissue biochemical and immunohistochemical predictors of response in patients treated with this regimen.
- Correlate carcinoembryonic antigen levels in the peripheral blood with response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive O6-benzylguanine (BG) IV over 1 hour and carmustine IV over 1 hour (beginning 1 hour after completion of BG infusion) on day 1. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study within 1.7-3 years.
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Smitha Krishnamurthi, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|