Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-21 @ 4:08 PM
Study NCT ID:
NCT00001495
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
1999-09
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:
This study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen.
Detailed Description:
Irinotecan (CPT-11) is a promising camptothecin analogue with activity in solid tumors. In Phase I studies using short intravenous infusion schedules, the predominant drug toxicities have been gastrointestinal, such as diarrhea, and myelosuppression. In animal studies, prolonged infusion schedules followed by short drug-free intervals have resulted in preservation of antitumor activity and decreased drug toxicity. Therefore, we propose to examine a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen. The duration of these treatments will be escalated in our Phase I study until patients are receiving therapy for 2 out of every 3 weeks. Standard Phase I drug toxicity and tumor response information will be monitored and the pharmacokinetics of irinotecan and its active metabolite, SN-38 will also be examined. We will also attempt to monitor the intracellular molecular effects of SN-38 therapy in blood, bone marrow, and, whenever possible, tumor tissue.
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 96-C-0013 | None | None | View |