NCT00005981

Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	O6-benzylguanine	Patients receive O6-benzylguanine (BG) IV over 1 hour. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
DRUG	carmustine	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.

Timeline

• Start date: 2000-06-01
• Primary completion: 2003-11-01
• Completion: 2003-11-01
• First posted: 2003-01-27
• Last updated: 2010-06-10

Locations

1 site across 1 country: United States