Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001426
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
1999-11-03
Brief Title:
A Multi-Institutional Phase II Study of Cyclophosphamide Paclitaxel Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Multi-Institutional Phase II Study of Cyclophosphamide Paclitaxel Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2013-11-07
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:
A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration CAI is a cytostatic drug and continuous exposure is needed This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel
Detailed Description:
A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration CAI is a cytostatic drug and continuous exposure is needed This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel
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 |
|---|---|---|---|
| 95-C-0055 | None | None | None |