S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

docetaxel

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

docetaxel

Arm Description

docetaxel

Outcomes

Primary Outcome Measures

Study treatment feasibility

Secondary Outcome Measures

Overall survival

Survival at 2 years

Response rate (confirmed and unconfirmed complete and partial response)

Toxicity and tolerability

Feasibility of standardized self-report measures of comorbidity, depression, and functional status

Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age

Full Information

NCT ID

NCT00025493

First Posted

October 11, 2001

Last Updated

January 22, 2013

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00025493

Brief Title

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

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Terminated

Why Stopped

poor accrual

Study Start Date

October 2001 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

docetaxel

Arm Type

Experimental

Arm Description

docetaxel

Intervention Type

Drug

Intervention Name(s)

docetaxel

Primary Outcome Measure Information:

Title

Study treatment feasibility

Time Frame

monthly for duration of accrual

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

at weeks 10 and 19, then every 3 months for 3 years

Title

Survival at 2 years

Time Frame

at weeks 10 and 19, then every 3 months for 2 years

Title

Response rate (confirmed and unconfirmed complete and partial response)

Time Frame

at weeks 10 and 19, then every 3 months for 3 years

Title

Toxicity and tolerability

Time Frame

at week 1, then every 3 weeks

Title

Feasibility of standardized self-report measures of comorbidity, depression, and functional status

Time Frame

upon completion of patient accrual

Title

Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age

Time Frame

upon completion of patient accrual

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Silvana Martino, DO

Organizational Affiliation

Saint John's Cancer Institute

Official's Role

Study Chair

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial