Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003130
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
1999-11-01
Brief Title:
Paclitaxel in Treating Women With Recurrent Solid Tumors
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Prospective Evaluation of Body Surface Area BSA as a Determinant of Paclitaxel PharmacokineticsPharmacodynamics in Women With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating women who have recurrent solid tumors
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating women who have recurrent solid tumors
Detailed Description:
OBJECTIVES I Evaluate the relationships between body surface area BSA and toxic effects BSA and pharmacokinetics and pharmacokinetics and toxic effects in women with recurrent solid tumors who receive a fixed total dose of paclitaxel II Determine the toxic effects of paclitaxel in these patients III Assess the pharmacokinetics of paclitaxel in these patients
OUTLINE Patients receive single fixed dose intravenous paclitaxel over 3 hours on day 1 Blood samples must be drawn prior to the first paclitaxel infusion and then at 1 6 and 24 hours after the start of the infusion during course 1 only Treatment courses of intravenous paclitaxel are repeated every 3 weeks at the discretion of the treating physician Patients are evaluated for response after the second course Patients are followed at the discretion of the physician
PROJECTED ACCRUAL A total of 50 patients will be accrued over 13 months
OUTLINE Patients receive single fixed dose intravenous paclitaxel over 3 hours on day 1 Blood samples must be drawn prior to the first paclitaxel infusion and then at 1 6 and 24 hours after the start of the infusion during course 1 only Treatment courses of intravenous paclitaxel are repeated every 3 weeks at the discretion of the treating physician Patients are evaluated for response after the second course Patients are followed at the discretion of the physician
PROJECTED ACCRUAL A total of 50 patients will be accrued over 13 months
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 |
|---|---|---|---|
| CDR0000065893 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-9763 | None | None | None |