Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079170
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2004-03-08
Brief Title:
Docetaxel Plus Garlic in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study to Evaluate the Influence of Garlic on the Pharmacokinetics of Docetaxel in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2006-10
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 such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether garlic supplements affect the ability of docetaxel to kill tumor cells
PURPOSE This clinical trial is studying how well giving docetaxel together with garlic works in treating patients with locally advanced or metastatic breast cancer
PURPOSE This clinical trial is studying how well giving docetaxel together with garlic works in treating patients with locally advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the clinical pharmacokinetic behavior of docetaxel with and without garlic tablets in patients with locally advanced or metastatic breast cancer
Determine the toxicity of this regimen in these patients
Secondary
Determine the incidence of enzyme and transporter polymorphism in patients treated with this regimen
OUTLINE This is a pilot open-label study
Patients receive docetaxel IV over 60 minutes on days 1 8 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity On days 5-17 of course 1 patients receive oral garlic twice daily Patients have the option of continuing garlic tablets as long as they remain on study
PROJECTED ACCRUAL A total of 9-12 patients will be accrued for this study within 6 months
Primary
Determine the clinical pharmacokinetic behavior of docetaxel with and without garlic tablets in patients with locally advanced or metastatic breast cancer
Determine the toxicity of this regimen in these patients
Secondary
Determine the incidence of enzyme and transporter polymorphism in patients treated with this regimen
OUTLINE This is a pilot open-label study
Patients receive docetaxel IV over 60 minutes on days 1 8 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity On days 5-17 of course 1 patients receive oral garlic twice daily Patients have the option of continuing garlic tablets as long as they remain on study
PROJECTED ACCRUAL A total of 9-12 patients will be accrued for this study within 6 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-04-C-0084 | None | None | None |