S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2008-06-01
• 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.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating older women who have metastatic breast cancer.

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel

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