Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047242
Status:
COMPLETED
Last Update Posted:
2010-08-09
First Post:
2002-10-03
Brief Title:
UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
The Pharmacokinetic and Safety Profile of UCN-01 in Combination With Irinotecan in Solid Tumors Primarily Lung Ovarian and GI Cancers
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining UCN-01 with chemotherapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining UCN-01 with irinotecan in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combining UCN-01 with irinotecan in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and irinotecan in patients with advanced solid tumors primarily lung ovarian and gastrointestinal tumors
Determine the acute and chronic toxicity profile of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine preliminarily the anti-tumor effect of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive UCN-01 IV over 3 hours on day 1 and irinotecan IV over 90 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of UCN-01 and irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the recommended phase II dose
Patients are followed at 1 month
PROJECTED ACCRUAL Approximately 20-30 patients will be accrued for this study within 7-15 months
Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and irinotecan in patients with advanced solid tumors primarily lung ovarian and gastrointestinal tumors
Determine the acute and chronic toxicity profile of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine preliminarily the anti-tumor effect of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive UCN-01 IV over 3 hours on day 1 and irinotecan IV over 90 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of UCN-01 and irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the recommended phase II dose
Patients are followed at 1 month
PROJECTED ACCRUAL Approximately 20-30 patients will be accrued for this study within 7-15 months
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 |
|---|---|---|---|
| U01CA070095 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J0173 | None | None | None |
| NCI-5528 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |