Docetaxel in Treating Older Women With Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: UNICANCER
• Treatments: Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

• Metastatic disease

• Measurable disease by CT scan or MRI

• Requires first-line chemotherapy for metastatic disease

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 70 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Meets both of the following criteria:

• Lawton's Instrumental Activities of Daily Living score ≥ 4

• Katz's Activities of Daily Living score ≥ 4

Life expectancy

• More than 3 months

Hematopoietic

• Hemoglobin > 10 g/dL

• Neutrophil count > 1,500/mm^3

• Platelet count > 100,000/mm^3

Hepatic

• ALT and AST < 1.5 times normal

• Bilirubin normal

• Alkaline phosphatase < 2.5 times normal

Renal

• Creatinine clearance > 30 mL/min

Cardiovascular

• No congestive heart failure

• No unstable angina pectoris

• No myocardial infarction within the past year

• No uncontrolled hypertension

• No high-risk uncontrolled arrhythmias

Other

• Geriatric Depression Score < 12

• No active uncontrolled infection

• No active peptic ulcer

• No uncontrolled diabetes mellitus

• No inflammatory bowel disease

• No history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80

• No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent

• No familial, social, geographical, or psychological condition that would preclude study follow-up

• No definite contraindication to corticosteroids

• No other serious illness or medical condition

• No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior or concurrent trastuzumab (Herceptin^®)

Chemotherapy

• Prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed

• More than 2 years since prior docetaxel or paclitaxel

• No other concurrent chemotherapy

Endocrine therapy

• No more than 1 prior hormonal therapy regimen for metastatic disease

• At least 10 days since prior hormonal therapy

• No concurrent hormonal therapy

• No concurrent chronic corticosteroids

• Concurrent low-dose corticosteroids (≤ 20 mg/day of methylprednisolone or equivalent) allowed provided treatment was initiated > 6 months before study entry

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 30 days since prior active treatment on another clinical trial

• Concurrent bisphosphonates allowed for bone metastases, osteoporosis, or osteopenia

• No other concurrent anticancer therapy

• No other concurrent investigational drugs