Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00005981
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States