Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042861
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2002-08-05
Brief Title:
UCN-01 Fluorouracil and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Pharmacologic Trial Of Infusional UCN-01 Given With A Weekly Schedule Of 5-Fluorouracil And Leucovorin
Status:
COMPLETED
Status Verified Date:
2003-04
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 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 fluorouracil and leucovorin in treating patients who have metastatic or unresectable solid tumors
PURPOSE Phase I trial to study the effectiveness of combining UCN-01 fluorouracil and leucovorin in treating patients who have metastatic or unresectable solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of fluorouracil when given in combination with UCN-01 and leucovorin calcium in patients with metastatic or unresectable solid tumors
Determine the clinical toxic effects of this regimen in these patients
Determine the pharmacokinetics of these drugs in these patients
Correlate if possible the pharmacokinetics of these drugs with clinical toxicity in these patients
Assess the pharmacodynamic effects of these drugs in these patients
Assess any clinical activity of this regimen in patients with measurable disease
OUTLINE This is a dose-escalation study of fluorouracil 5-FU
Patients receive leucovorin calcium CF IV over 2 hours and 5-FU IV at the midpoint of CF administration on day 1 followed by UCN-01 IV over 36-72 hours on weeks 1-3 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 5-FU until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity The recommended phase II dose RPIID is defined as the dose preceding the MTD At least 6 additional patients are treated at the RPIID
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 16 months
Determine the maximum tolerated dose of fluorouracil when given in combination with UCN-01 and leucovorin calcium in patients with metastatic or unresectable solid tumors
Determine the clinical toxic effects of this regimen in these patients
Determine the pharmacokinetics of these drugs in these patients
Correlate if possible the pharmacokinetics of these drugs with clinical toxicity in these patients
Assess the pharmacodynamic effects of these drugs in these patients
Assess any clinical activity of this regimen in patients with measurable disease
OUTLINE This is a dose-escalation study of fluorouracil 5-FU
Patients receive leucovorin calcium CF IV over 2 hours and 5-FU IV at the midpoint of CF administration on day 1 followed by UCN-01 IV over 36-72 hours on weeks 1-3 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 5-FU until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity The recommended phase II dose RPIID is defined as the dose preceding the MTD At least 6 additional patients are treated at the RPIID
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 16 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-02-C-0222 | None | None | None |
| NCI-NAVY-01-04 | None | None | None |
| NCI-5535 | None | None | None |