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S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer

This study has been terminated.
(poor accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00025493
First received: October 11, 2001
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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:

Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Study treatment feasibility [ Time Frame: monthly for duration of accrual ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: at weeks 10 and 19, then every 3 months for 3 years ] [ Designated as safety issue: No ]
  • Survival at 2 years [ Time Frame: at weeks 10 and 19, then every 3 months for 2 years ] [ Designated as safety issue: No ]
  • Response rate (confirmed and unconfirmed complete and partial response) [ Time Frame: at weeks 10 and 19, then every 3 months for 3 years ] [ Designated as safety issue: No ]
  • Toxicity and tolerability [ Time Frame: at week 1, then every 3 weeks ] [ Designated as safety issue: Yes ]
  • Feasibility of standardized self-report measures of comorbidity, depression, and functional status [ Time Frame: upon completion of patient accrual ] [ Designated as safety issue: No ]
  • Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age [ Time Frame: upon completion of patient accrual ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: October 2001
Study Completion Date: June 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: docetaxel
docetaxel
 Drug: docetaxel

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

Ages Eligible for Study:   18 Years and older
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

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00025493     History of Changes
Other Study ID Numbers: CDR0000068966, U10CA032102, S0029
Study First Received: October 11, 2001
Last Updated: January 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013