Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Calcium; Fluorouracil; Leucovorin; Levoleucovorin; Mitoxantrone

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