Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001383
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833
Status:
COMPLETED
Status Verified Date:
2000-03
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:
This is a dosage escalation study to estimate the maximum tolerated dose of drug resistance inhibitor PSC 833 given in combination with paclitaxel Groups of 3 to 6 patients receive continuous-infusion paclitaxel for 5 days and oral PSC 833 for 6-7 days following paclitaxel on the first course then beginning 3 days prior to paclitaxel on subsequent courses
Stable and responding patients are re-treated every 21 days with paclitaxel dose adjusted to maintain an absolute neutrophil count less than 500 for no more than 4 days
Stable and responding patients are re-treated every 21 days with paclitaxel dose adjusted to maintain an absolute neutrophil count less than 500 for no more than 4 days
Detailed Description:
The clinical study entitled A Phase I Study of Infusional Paclitaxel with the P-glycoprotein Antagonist PSC 833 seeks to determine the maximum tolerated dose for the proposed P-glycoprotein antagonist PSC 833 in combination with paclitaxel PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive It has been shown in in vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable The purpose of this study is to define the maximum tolerated dose in combination with paclitaxel and to determine how the drug affects the pharmacokinetics of paclitaxel PSC 833 will most likely reduce the clearance of paclitaxel as reported for the parent compound cyclosporine This effect will increase the area under the curve AUC of paclitaxel may increase toxicity and requires that the escalation scheme for PSC 833 be a conservative one The first cycle of paclitaxel will be given in the absence of PSC 833 Subsequently 7 days of PSC 833 will be given alone to allow monitoring of pharmacokinetics and adverse effects of PSC 833 alone In the second cycle both agents will be combined Escalation of the PSC 833 will continue until a target concentration is reached or until the maximum tolerated dose is reached Clinical responses will be monitored in order to provide the best possible medical care to our patients
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-0119 | None | None | None |