NCT00025493

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_2 breast-cancer

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

5.7 years

First QC Date

October 11, 2001

Last Update Submit

January 22, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (1)

  • Study treatment feasibility

    monthly for duration of accrual

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

docetaxel

EXPERIMENTAL

docetaxel

Drug: docetaxel

Interventions

docetaxelDRUG
docetaxel

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Silvana Martino, DO

    Saint John's Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

October 1, 2001

Primary Completion

June 1, 2007

Study Completion

June 1, 2008

Last Updated

January 24, 2013

Record last verified: 2013-01