Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024141
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2001-09-13
Brief Title:
Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors A Pilot Study
Status:
COMPLETED
Status Verified Date:
2011-03
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
PURPOSE Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors
Determine the toxic effects of this regimen in these patients
Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients
Assess in a preliminary manner the antitumor activity of this regimen in these patients
OUTLINE This is a dose de-escalation study of irinotecan
Patients receive irinotecan IV over 90 minutes on days 1 8 15 and 22 and fluorouracil IV over 5 minutes on days 2 9 16 and 23 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study within 12-18 months
Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors
Determine the toxic effects of this regimen in these patients
Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients
Assess in a preliminary manner the antitumor activity of this regimen in these patients
OUTLINE This is a dose de-escalation study of irinotecan
Patients receive irinotecan IV over 90 minutes on days 1 8 15 and 22 and fluorouracil IV over 5 minutes on days 2 9 16 and 23 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study within 12-18 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 |
|---|---|---|---|
| RPCI-RP-01-01 | None | None | None |