Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004051
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-12-10
Brief Title:
Irinotecan in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study to Evaluate Orally Administered Irinotecan HCL CPT-11 Given as a Powder-Filled Capsule Formulation Daily for 14 Days Every Three Weeks in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2009-12
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 in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of irinotecan in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose dose limiting toxicity and safety profile of oral irinotecan in patients with advanced solid tumors II Characterize the single and multiple dose pharmacokinetics of oral irinotecan and its metabolites SN-38 and SN-38 glucuronide in these patients III Document any antitumor activity in these patients treated with this regimen
OUTLINE This is a dose escalation study Patients receive oral irinotecan once daily for 14 days Courses repeat every 3 weeks 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 or more of 6 patients experience dose limiting toxicity Patients are followed monthly for 6 months
PROJECTED ACCRUAL Approximately 3-40 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive oral irinotecan once daily for 14 days Courses repeat every 3 weeks 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 or more of 6 patients experience dose limiting toxicity Patients are followed monthly for 6 months
PROJECTED ACCRUAL Approximately 3-40 patients will be accrued for this study
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 |
|---|---|---|---|
| MSKCC-98076 | None | None | None |
| P-UPJOHN-976475155 | None | None | None |
| NCI-G99-1569 | None | None | None |