Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028015
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2001-12-07
Brief Title:
SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study of Second-Line SarCNU NSC 364432 in Patients With RecurrentMetastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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
PURPOSE Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent or metastatic colorectal cancer
PURPOSE Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent or metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of SarCNU in patients with recurrent or metastatic colorectal cancer
Determine the qualitative and quantitative toxicity of this drug in these patients
Determine the time to progression and survival of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral SarCNU on days 1 5 and 9 Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR receive 2 additional courses beyond documentation of CR Patients who achieve partial response PR receive 4 additional courses beyond documentation of PR
Patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 6-8 months
Determine the efficacy of SarCNU in patients with recurrent or metastatic colorectal cancer
Determine the qualitative and quantitative toxicity of this drug in these patients
Determine the time to progression and survival of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral SarCNU on days 1 5 and 9 Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR receive 2 additional courses beyond documentation of CR Patients who achieve partial response PR receive 4 additional courses beyond documentation of PR
Patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 6-8 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069113 | OTHER | PDQ | None |
| CAN-NCIC-IND146 | OTHER | None | None |