S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 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 ]
|Study Start Date:||October 2001|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025493
|Study Chair:||Silvana Martino, DO||John Wayne Cancer Institute|