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Docetaxel in Treating Older Women With Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
Study NCT00025493   Information provided by National Cancer Institute (NCI)
First Received: October 11, 2001   Last Updated: July 23, 2008   History of Changes

October 11, 2001
July 23, 2008
October 2001
 
 
 
Complete list of historical versions of study NCT00025493 on ClinicalTrials.gov Archive Site
 
 
 
Docetaxel in Treating Older Women With Metastatic Breast Cancer
Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger Than 60 Years)

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.

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.

Phase II
Interventional
Treatment
Breast Cancer
Drug: docetaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Female
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00025493
 
CDR0000068966, SWOG-S0029
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Silvana Martino, DO John Wayne Cancer Institute at Saint John's Health Center
National Cancer Institute (NCI)
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP