Status:
TERMINATED
Docetaxel in Treating Older Women With Metastatic Breast Cancer
Lead Sponsor:
UNICANCER
Conditions:
Breast Cancer
Eligibility:
FEMALE
70+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Determine degree of autonomy in instrumental activities of daily living on-therapy and at 6 and 12 months, as measured by Lawton's Instrumental Activities of Daily Living Scale...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00104624
Start Date
May 1 2005
End Date
July 1 2008
Last Update
September 4 2013
Active Locations (7)
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1
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
2
Institut Curie Hopital
Paris, France, 75248
3
Centre Henri Becquerel
Rouen, France, 76038
4
C.H. Senlis
Senlis, France, 60309