Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger Than 60 Years)
18 Years
N/A
Female
Breast Cancer
Trial Information
Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger Than 60 Years)
OBJECTIVES:
- Determine the feasibility of treating elderly women with metastatic breast cancer with
docetaxel.
- Determine the overall survival, 2-year survival, and response (confirmed and
unconfirmed complete and partial) in patients treated with this drug.
- Determine the toxicity and tolerability of this drug in these patients.
- Determine the feasibility of using standardized self-report measures of comorbidity,
depression, and functional status in elderly cancer patients.
- Determine the parameters of clinical pharmacology of this drug in elderly patients and
in patients under 60 years of age.
- Determine, preliminarily, the genetic polymorphisms and gene expression levels of
enzymes involved in drug metabolism and resistance in patients treated with this drug.
OUTLINE: Patients are stratified according to age (70 and over vs under 60).
Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: Approximately 80 patients (60 patients age 70 and over and 20 patients
under age 60) will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Distant metastatic disease confirmed by histology, cytology, or strong clinical
evidence
- Measurable disease
- No known brain or CNS metastases
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 70 and over OR
- Under 60
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Hemoglobin at least 9 g/dL
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- SGOT or SGPT no greater than 1.5 times ULN (2.0 times ULN if liver metastases are
present)
- Alkaline phosphatase no greater than 1.5 times ULN (2.0 times ULN if liver metastases
are present)
Renal:
- Creatinine no greater than ULN
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately
treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy for breast cancer
Chemotherapy:
- Prior adjuvant or neoadjuvant chemotherapy allowed
- Prior adjuvant taxanes allowed
- No other concurrent chemotherapy for breast cancer
Endocrine therapy:
- Prior hormonal therapy in the adjuvant setting or for metastatic disease allowed
- No concurrent hormonal therapy for breast cancer
Radiotherapy:
- No concurrent radiotherapy for breast cancer
Surgery:
- Not specified
Other
- No more than 1 prior regimen for advanced, recurrent, or metastatic disease
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Study treatment feasibility
Outcome Time Frame:
monthly for duration of accrual
Safety Issue:
No
Principal Investigator
Silvana Martino, DO
Investigator Role:
Study Chair
Investigator Affiliation:
John Wayne Cancer Institute at Saint John's Health Center
Authority:
United States: Federal Government
Study ID:
CDR0000068966
NCT ID:
NCT00025493
Start Date:
October 2001
Completion Date:
June 2008
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
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