Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT00010075

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

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

Detailed Description

OBJECTIVES:

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women

Study Start Date :

Jan 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed metastatic adenocarcinoma of the breast
Bidimensionally measurable or evaluable disease
At least one non-irradiated lesion that is at least 2 cm in the greater diameter OR
Serous drainage, cutaneous metastasis, osseous metastasis, etc.
No symptomatic cerebral metastasis
Hormone receptor status:
Not specified

PATIENT CHARACTERISTICS:

Age:

75 to 90

Sex:

Female

Menopausal status:

Postmenopausal

Performance status:

WHO 0-2

Life expectancy:

At least 3 months

Hematopoietic:

Platelet count at least 100,000/mm^3
Absolute neutrophil count at least 1,500/mm^3

Hepatic:

Alkaline phosphatase less than 3 times normal
Bilirubin less than 1.5 times normal
Transaminases less than 3 times normal
Total protein greater than 60%
Albumin greater than 30 g/L

Renal:

Creatinine clearance greater than 60 mL/min

Cardiovascular:

LVEF greater than 50% by echocardiogram or scintigraph
ECG normal
No uncontrolled angina
No myocardial infarction within past 6 months

Other:

No other medical illness or condition that would preclude study
No other prior malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the cervix
No psychological, social, familial, or geographical reasons that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Prior adjuvant chemotherapy allowed
No prior adjuvant anthracyclines
No prior chemotherapy for metastatic disease

Endocrine therapy:

One or two prior regimens of hormonal therapy allowed for metastatic disease

Radiotherapy:

No prior radiotherapy for metastatic disease

Surgery:

Not specified

Other:

No concurrent participation in another study

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier Victor Dupouy	Argenteuil	France	95107
2	Polyclinique De Courlancy	Metz	France	55038
3	Hopital Saint Antoine	Paris	France	75571
4	Hopital Tenon	Paris	France	75970
5	C.H. Senlis	Senlis	France	60309
6	Centre Medico-Chirurgical Foch	Suresnes	France	92151