Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003565
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
1999-11-01
Brief Title:
Docetaxel in Treating Patients With Solid Tumors
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Study of Population Pharmacokinetics of Docetaxel Taxotere in Caucasian and African-American Cancer Patients
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 compare the effectiveness of docetaxel in treating Caucasian and African American patients who have solid tumors
PURPOSE Phase II trial to compare the effectiveness of docetaxel in treating Caucasian and African American patients who have solid tumors
Detailed Description:
OBJECTIVES
Compare the population pharmacokinetics of docetaxel in Caucasians and African American patients with solid tumors
Compare the pharmacodynamic effect of a single dose of docetaxel in relation to hematological toxicity in these patient populations
Determine the CYP3A4 genotype and P-glycoprotein P-gp expression and their relationship to docetaxel clearance in these patient populations
OUTLINE Patients receive docetaxel IV over 1 hour on day 1 Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician
Compare the population pharmacokinetics of docetaxel in Caucasians and African American patients with solid tumors
Compare the pharmacodynamic effect of a single dose of docetaxel in relation to hematological toxicity in these patient populations
Determine the CYP3A4 genotype and P-glycoprotein P-gp expression and their relationship to docetaxel clearance in these patient populations
OUTLINE Patients receive docetaxel IV over 1 hour on day 1 Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician
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 |
|---|---|---|---|
| CDR0000066631 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-9871 | None | None | None |