Clinical trial NCT00025493: S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Study treatment feasibility
timeFrame: monthly for duration of accrual
Secondary outcomes:
measure: Overall survival
timeFrame: at weeks 10 and 19, then every 3 months for 3 years
measure: Survival at 2 years
timeFrame: at weeks 10 and 19, then every 3 months for 2 years
measure: Response rate (confirmed and unconfirmed complete and partial response)
timeFrame: at weeks 10 and 19, then every 3 months for 3 years
measure: Toxicity and tolerability
timeFrame: at week 1, then every 3 weeks
measure: Feasibility of standardized self-report measures of comorbidity, depression, and functional status
timeFrame: upon completion of patient accrual
measure: Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age
timeFrame: upon completion of patient accrual
Other outcomes:
Locations:
Study officials:
affiliation: Saint John's Cancer Institute
name: Silvana Martino, DO
role: STUDY_CHAIR
References: