S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer
- Registration Number
- NCT00025493
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description docetaxel docetaxel docetaxel
- Primary Outcome Measures
Name Time Method Study treatment feasibility monthly for duration of accrual
- Secondary Outcome Measures
Name Time Method Overall survival at weeks 10 and 19, then every 3 months for 3 years Survival at 2 years at weeks 10 and 19, then every 3 months for 2 years Response rate (confirmed and unconfirmed complete and partial response) at weeks 10 and 19, then every 3 months for 3 years Toxicity and tolerability at week 1, then every 3 weeks Feasibility of standardized self-report measures of comorbidity, depression, and functional status upon completion of patient accrual Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age upon completion of patient accrual