S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00025493|
Recruitment Status : Terminated (poor accrual)
First Posted : January 27, 2003
Last Update Posted : January 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: docetaxel||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2008|
- Study treatment feasibility [ Time Frame: monthly for duration of accrual ]
- Overall survival [ Time Frame: at weeks 10 and 19, then every 3 months for 3 years ]
- Survival at 2 years [ Time Frame: at weeks 10 and 19, then every 3 months for 2 years ]
- Response rate (confirmed and unconfirmed complete and partial response) [ Time Frame: at weeks 10 and 19, then every 3 months for 3 years ]
- Toxicity and tolerability [ Time Frame: at week 1, then every 3 weeks ]
- Feasibility of standardized self-report measures of comorbidity, depression, and functional status [ Time Frame: upon completion of patient accrual ]
- Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age [ Time Frame: upon completion of patient accrual ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025493
|Study Chair:||Silvana Martino, DO||John Wayne Cancer Institute|