Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054288
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2003-02-05
Brief Title:
Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Escalating Irinotecan CPT-11 Administered 24 Hours Prior To Gemcitabine In Patients With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-01
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 combining irinotecan with gemcitabine in treating patients who have refractory advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combining irinotecan with gemcitabine in treating patients who have refractory advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of irinotecan when administered with gemcitabine in patients with refractory advanced solid tumors
Determine the antitumor activity and toxicity of this regimen in these patients
Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients
Determine the optimal dose and time interval for this regimen in these patients
OUTLINE This is an open-label non-randomized dose-escalation study of irinotecan
Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9 Courses repeat every 21 days 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 The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 2 years
Determine the maximum tolerated dose of irinotecan when administered with gemcitabine in patients with refractory advanced solid tumors
Determine the antitumor activity and toxicity of this regimen in these patients
Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients
Determine the optimal dose and time interval for this regimen in these patients
OUTLINE This is an open-label non-randomized dose-escalation study of irinotecan
Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9 Courses repeat every 21 days 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 The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 2 years
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-DS-01-18 | None | None | None |