Docetaxel in Treating Older Women With Metastatic Breast Cancer - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00025493

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: docetaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 2001

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025493

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Silvana Martino, DO

John Wayne Cancer Institute at Saint John's Health Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068966, SWOG-S0029
Study First Received:	October 11, 2001
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00025493 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents

Therapeutic Uses
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009