Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020488
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2001-07-11
Brief Title:
Combination Chemotherapy in Treating Patients Who Have Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Pharmacologic Trial Of Sequential Irinotecan As A 24-Hour IV Infusion Leucovorin Flurouracil As A 48-Hour IV Infusion In Adult Cancer Patients
Status:
COMPLETED
Status Verified Date:
2003-09
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the recommended phase II dose of irinotecan leucovorin calcium and fluorouracil in patients with advanced solid tumors
Determine the toxic effects of this regimen in these patients
Determine the pharmacokinetic and pharmacodynamic profiles of irinotecan and fluorouracil in patients treated with this regimen
Determine the correlation of polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity and response in patients treated with this regimen
Determine the correlation of polymorphisms in the uridine diphosphate glucuronosyltransferase 1A1 gene promoter with the extent of SN-38 glucuronidation and severity of diarrhea in patients treated with this regimen
Assess any anti-tumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of irinotecan and fluorouracil
Patients receive irinotecan IV continuously over 24 hours on days 1 and 15 and leucovorin calcium IV over 30 minutes followed by fluorouracil IV continuously over 48 hours on days 2 and 16 Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined Once the MTD of irinotecan has been determined additional cohorts receive escalating doses of fluorouracil until the 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
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study within 20 months
Determine the recommended phase II dose of irinotecan leucovorin calcium and fluorouracil in patients with advanced solid tumors
Determine the toxic effects of this regimen in these patients
Determine the pharmacokinetic and pharmacodynamic profiles of irinotecan and fluorouracil in patients treated with this regimen
Determine the correlation of polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity and response in patients treated with this regimen
Determine the correlation of polymorphisms in the uridine diphosphate glucuronosyltransferase 1A1 gene promoter with the extent of SN-38 glucuronidation and severity of diarrhea in patients treated with this regimen
Assess any anti-tumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of irinotecan and fluorouracil
Patients receive irinotecan IV continuously over 24 hours on days 1 and 15 and leucovorin calcium IV over 30 minutes followed by fluorouracil IV continuously over 48 hours on days 2 and 16 Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined Once the MTD of irinotecan has been determined additional cohorts receive escalating doses of fluorouracil until the 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
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study within 20 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 |
|---|---|---|---|
| MB-NAVY-B00-038 | None | None | None |
| NCI-01-C-0082 | None | None | None |
| MB-NAVY-00-02 | None | None | None |