S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer

NCT ID: NCT00025493

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2008-06-30

Brief 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.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

docetaxel

docetaxel

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

Interventions

docetaxel

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvana Martino, DO

Role: STUDY_CHAIR

Saint John's Cancer Institute

Other Identifiers

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S0029

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000068966

Identifier Type: -

Identifier Source: org_study_id