S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer

Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00025493
• Other study ID #: CDR0000068966
• Secondary ID: U10CA032102S0029
• Status: Terminated
• Phase: Phase 2
• First received: October 11, 2001
• Last updated: January 22, 2013
• Start date: October 2001
• Est. completion date: June 2008

Study information

• Verified date: January 2013
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: June 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study treatment feasibility		monthly for duration of accrual	No
Secondary	Overall survival		at weeks 10 and 19, then every 3 months for 3 years	No
Secondary	Survival at 2 years		at weeks 10 and 19, then every 3 months for 2 years	No
Secondary	Response rate (confirmed and unconfirmed complete and partial response)		at weeks 10 and 19, then every 3 months for 3 years	No
Secondary	Toxicity and tolerability		at week 1, then every 3 weeks	Yes
Secondary	Feasibility of standardized self-report measures of comorbidity, depression, and functional status		upon completion of patient accrual	No
Secondary	Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age		upon completion of patient accrual	No