Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004059
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-12-10
Brief Title:
Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Study of the Cyclin-Dependent Kinase CDKProtein Kinase C PKC Inhibitor UCN-01 NSC 638850 in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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 UCN-01 may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug
PURPOSE Phase I trial to study the effectiveness of fluorouracil plus UCN-01 in treating patients who have advanced or refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of fluorouracil plus UCN-01 in treating patients who have advanced or refractory solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose dose limiting toxicity and toxicity profile of fluorouracil with UCN-01 in patients with advanced or refractory solid tumors
Assess the clinical pharmacokinetics of this regimen and correlate with observed toxicities in these patients
Obtain preliminary data on the therapeutic activity of this regimen in these patients
OUTLINE This is a dose escalation study of fluorouracil
Patients receive fluorouracil IV over 24 hours on days 1 8 15 and 22 Patients receive an initial dose of UCN-01 IV over 72 hours beginning on day 2 during course 1 and then maintenance UCN-01 IV over 36 hours beginning on day 2 during subsequent courses Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of fluorouracil 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
PROJECTED ACCRUAL Approximately 6-48 patients will be accrued for this study within approximately 14 months
Determine the maximum tolerated dose dose limiting toxicity and toxicity profile of fluorouracil with UCN-01 in patients with advanced or refractory solid tumors
Assess the clinical pharmacokinetics of this regimen and correlate with observed toxicities in these patients
Obtain preliminary data on the therapeutic activity of this regimen in these patients
OUTLINE This is a dose escalation study of fluorouracil
Patients receive fluorouracil IV over 24 hours on days 1 8 15 and 22 Patients receive an initial dose of UCN-01 IV over 72 hours beginning on day 2 during course 1 and then maintenance UCN-01 IV over 36 hours beginning on day 2 during subsequent courses Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of fluorouracil 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
PROJECTED ACCRUAL Approximately 6-48 patients will be accrued for this study within approximately 14 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 |
|---|---|---|---|
| NCI-T99-0037 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067256 | REGISTRY | None | None |