Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00005981|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 10, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: O6-benzylguanine Drug: carmustine||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma|
|Study Start Date :||June 2000|
|Primary Completion Date :||November 2003|
|Study Completion Date :||November 2003|
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005981
|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|