Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Phase 2

Completed

• 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.

Study Timeline

• Study Start: 2000-06
• Study First Submitted: 2000-07-05
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-11
• Study Completion: 2003-11
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-09
• Last Update Posted: 2010-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Trial Locations

Locations (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States