Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021268
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2001-07-11
Brief Title:
Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study Of Tocladesine In Patients With Colorectal Carcinoma Following Therapy With 5-FU And Irinotecan
Status:
UNKNOWN
Status Verified Date:
2002-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 I trial to study the effectiveness of tocladesine in treating patients who have recurrent or progressive metastatic colorectal cancer
PURPOSE Phase I trial to study the effectiveness of tocladesine in treating patients who have recurrent or progressive metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of tocladesine in patients with recurrent or progressive metastatic colorectal cancer
Determine the qualitative and quantitative toxicity of this drug in these patients
Assess any therapeutic activity in patients treated with this drug
OUTLINE This is a dose-escalation multicenter study
Patients receive tocladesine IV continuously on days 1-5 and 8-12 Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tocladesine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined up to 14 additional patients are treated at this dose level
PROJECTED ACCRUAL A total of 3-38 patients will be accrued for this study
Determine the maximum tolerated dose of tocladesine in patients with recurrent or progressive metastatic colorectal cancer
Determine the qualitative and quantitative toxicity of this drug in these patients
Assess any therapeutic activity in patients treated with this drug
OUTLINE This is a dose-escalation multicenter study
Patients receive tocladesine IV continuously on days 1-5 and 8-12 Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tocladesine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined up to 14 additional patients are treated at this dose level
PROJECTED ACCRUAL A total of 3-38 patients will be accrued for this study
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-G01-1979 | Registry Identifier | PDQ Physician Data Query | None |
| UCLA-0006008 | None | None | None |
| CDR0000068764 | REGISTRY | None | None |