Trials / Terminated
TerminatedNCT00025493
S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- SWOG Cancer Research Network · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | docetaxel |
Timeline
- Start date
- 2001-10-01
- Primary completion
- 2007-06-01
- Completion
- 2008-06-01
- First posted
- 2003-01-27
- Last updated
- 2013-01-24
Source: ClinicalTrials.gov record NCT00025493. Inclusion in this directory is not an endorsement.