Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025493
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2001-10-11
Brief Title:
S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older and in a Cohort of Patients Younger Than 60 Years
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
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 docetaxel in treating older women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of docetaxel in treating older women who have metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of treating elderly women with metastatic breast cancer with docetaxel
Determine the overall survival 2-year survival and response confirmed and unconfirmed complete and partial in patients treated with this drug
Determine the toxicity and tolerability of this drug in these patients
Determine the feasibility of using standardized self-report measures of comorbidity depression and functional status in elderly cancer patients
Determine the parameters of clinical pharmacology of this drug in elderly patients and in patients under 60 years of age
Determine preliminarily the genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance in patients treated with this drug
OUTLINE Patients are stratified according to age 70 and over vs under 60
Patients receive docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 3 years
PROJECTED ACCRUAL Approximately 80 patients 60 patients age 70 and over and 20 patients under age 60 will be accrued for this study
Determine the feasibility of treating elderly women with metastatic breast cancer with docetaxel
Determine the overall survival 2-year survival and response confirmed and unconfirmed complete and partial in patients treated with this drug
Determine the toxicity and tolerability of this drug in these patients
Determine the feasibility of using standardized self-report measures of comorbidity depression and functional status in elderly cancer patients
Determine the parameters of clinical pharmacology of this drug in elderly patients and in patients under 60 years of age
Determine preliminarily the genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance in patients treated with this drug
OUTLINE Patients are stratified according to age 70 and over vs under 60
Patients receive docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 3 years
PROJECTED ACCRUAL Approximately 80 patients 60 patients age 70 and over and 20 patients under age 60 will be accrued for this study
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 |
|---|---|---|---|
| S0029 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |