S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer

This study has been terminated.
(poor accrual)
Sponsor:
Collaborator:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Silvana Martino, DO John Wayne Cancer Institute at Saint John's Health Center
  More Information

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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014