Docetaxel in Treating Older Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00104624|
Recruitment Status : Terminated (Toxicity issues)
First Posted : March 4, 2005
Last Update Posted : September 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: docetaxel Procedure: quality-of-life assessment||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2005|
|Primary Completion Date :||July 2007|
|Study Completion Date :||July 2008|
- 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
- Response rate
- Overall survival
- Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale
- Progression-free survival
- Mood status as measured by the Geriatric Depression Scale
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): 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|