S0029 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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: docetaxel	Drug: docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Study treatment feasibility	monthly for duration of accrual

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	at weeks 10 and 19, then every 3 months for 3 years
Survival at 2 years	at weeks 10 and 19, then every 3 months for 2 years
Response rate (confirmed and unconfirmed complete and partial response)	at weeks 10 and 19, then every 3 months for 3 years
Toxicity and tolerability	at week 1, then every 3 weeks
Feasibility of standardized self-report measures of comorbidity, depression, and functional status	upon completion of patient accrual
Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age	upon completion of patient accrual

Collaborators and Investigators

• Sponsor: Southwest Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Silvana Martino, DO, Saint John's Cancer Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: October 11, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 22, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: stage IV breast cancer; recurrent breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: CDR0000068966; U10CA032102 (U.S. NIH Grant/Contract); S0029 (Other Identifier: SWOG)