Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005981
Status:
COMPLETED
Last Update Posted:
2010-06-10
First Post:
2000-07-05
Brief Title:
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 17-3 years
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 17-3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-89 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| U01CA063200 | NIH | None | None |
| P30CA043703 | NIH | None | None |
| CWRU-1298 | None | None | None |