Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001387
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Phase I and Pharmacokinetic Trial of Paclitaxel Taxol Given as a 3-Hour Infusion in Pediatric Patients With Refractory Malignancy
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I and Pharmacokinetic Trial of Paclitaxel Taxol Given as a 3-Hour Infusion in Pediatric Patients With Refractory Malignancy
Status:
COMPLETED
Status Verified Date:
1999-08
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:
The objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy
Detailed Description:
Paclitaxel is an active antitumor agent that has demonstrated a broad range of activity in preclinical and clinical studies The optimal dose and schedule has not yet been determined in either adults or children The objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy In addition the pharmacokinetics of paclitaxel given in this way will be studied and both model-dependent and model-independent parameters will be determined
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 |
|---|---|---|---|
| 94-C-0204 | None | None | None |