Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Docetaxel in Treating Older Women With Metastatic Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	70 and over OR Under 60	NCI	SWOG-S0029 S0029, NCT00025493

Objectives

1. Determine the feasibility of treating elderly women with metastatic breast cancer with docetaxel.
2. Determine the overall survival, 2-year survival, and response (confirmed and unconfirmed complete and partial) in patients treated with this drug.
3. Determine the toxicity and tolerability of this drug in these patients.
4. Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in elderly cancer patients.
5. Determine the parameters of clinical pharmacology of this drug in elderly patients and in patients under 60 years of age.
6. Determine, preliminarily, the genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance in patients treated with this drug.

Entry 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

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

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/mm³
• Hemoglobin at least 9 g/dL
• Platelet count at least 100,000/mm³

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

Expected Enrollment

Approximately 80 patients (60 patients age 70 and over and 20 patients under age 60) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Silvana Martino, DO, Protocol chair		Ph: 310-582-7900 Email: martinos@jwci.org

Registry Information
Official Title		Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients younger than 60 Years)
Trial Start Date		2001-10-01
Registered in ClinicalTrials.gov		NCT00025493
Date Submitted to PDQ		2001-08-17
Information Last Verified		2005-06-10
NCI Grant/Contract Number		U10-CA32102

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