Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00010075|
Recruitment Status : Unknown
Verified June 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : July 24, 2008
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: fluorouracil Drug: leucovorin calcium Drug: mitoxantrone hydrochloride||Phase 2|
- Determine the survival without degradation of quality of life in elderly women with metastatic breast cancer treated with leucovorin calcium, fluorouracil, and mitoxantrone.
- Determine the efficacy of this regimen, in terms of response and survival without progression, in these patients.
- Determine the tolerance of these patients to this regimen.
OUTLINE: This is a multicenter study.
Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1. Patients then receive fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after 3 courses, and at treatment completion.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women|
|Study Start Date :||January 2000|
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): NCT00010075
|Centre Hospitalier Victor Dupouy|
|Argenteuil, France, 95107|
|Polyclinique De Courlancy|
|Metz, France, 55038|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75970|
|Senlis, France, 60309|
|Centre Medico-Chirurgical Foch|
|Suresnes, France, 92151|
|Study Chair:||Elisabeth Carola, MD||C.H. Senlis|