Trial | NCT00010075  Report issue

Title

Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    None
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.
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 Started
Jan 31
2000
Last Update
Jul 24
2008
Estimate

Drug fluorouracil

Drug leucovorin calcium

Drug mitoxantrone hydrochloride

Criteria 

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
No Results Posted