Docetaxel in Treating Older Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.
Procedure: quality-of-life assessment
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy With Biweekly Docetaxel in the Treatment of Metastatic Breast Cancer in Patients Over 70|
- Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Mood status as measured by the Geriatric Depression Scale [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||May 2005|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- Determine degree of autonomy in instrumental activities of daily living on-therapy and at 6 and 12 months, as measured by Lawton's Instrumental Activities of Daily Living Scale, in older women with metastatic adenocarcinoma of the breast treated with docetaxel.
- Determine the response rate in patients treated with this drug.
- Determine overall and progression-free survival of patients treated with this drug.
- Determine the degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale, in patients treated with this drug.
- Determine mood status, as measured by the Geriatric Depression Scale, of patients treated with this drug.
- Determine toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV on days 1 and 15. Treatment repeats every 28 days for 6 courses.
Ability to perform daily activities is assessed periodically.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104624
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Institut Curie Hopital|
|Paris, France, 75248|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Senlis, France, 60309|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Istituto Nazionale Di Riposo e Cura per Anziani|
|Rome, Italy, 00189|
|Clinique De Genolier|
|Genolier, Switzerland, Ch-1272|
|Study Chair:||Suzette Delaloge||Gustave Roussy, Cancer Campus, Grand Paris|