Docetaxel in Treating Older Women With Metastatic Breast Cancer

September 2, 2013 updated by: UNICANCER

Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy With Biweekly Docetaxel in the Treatment of Metastatic Breast Cancer in Patients Over 70

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine degree of autonomy in instrumental activities of daily living on-therapy and at 6 and 12 months, as measured by Lawton's Instrumental Activities of Daily Living Scale, in older women with metastatic adenocarcinoma of the breast treated with docetaxel.

Secondary

  • Determine the response rate in patients treated with this drug.
  • Determine overall and progression-free survival of patients treated with this drug.
  • Determine the degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale, in patients treated with this drug.
  • Determine mood status, as measured by the Geriatric Depression Scale, of patients treated with this drug.
  • Determine toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV on days 1 and 15. Treatment repeats every 28 days for 6 courses.

Ability to perform daily activities is assessed periodically.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13273
        • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
      • Paris, France, 75248
        • Institut Curie Hopital
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Senlis, France, 60309
        • C.H. Senlis
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Italy
      • Rome, Italy, 00189
        • Istituto Nazionale di Riposo e Cura per Anziani
  • Switzerland
      • Genolier, Switzerland, Ch-1272
        • Clinique de Genolier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast

    • Metastatic disease
  • Measurable disease by CT scan or MRI
  • Requires first-line chemotherapy for metastatic disease

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 70 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • Meets both of the following criteria:

    • Lawton's Instrumental Activities of Daily Living score ≥ 4
    • Katz's Activities of Daily Living score ≥ 4

Life expectancy

  • More than 3 months

Hematopoietic

  • Hemoglobin > 10 g/dL
  • Neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3

Hepatic

  • ALT and AST < 1.5 times normal
  • Bilirubin normal
  • Alkaline phosphatase < 2.5 times normal

Renal

  • Creatinine clearance > 30 mL/min

Cardiovascular

  • No congestive heart failure
  • No unstable angina pectoris
  • No myocardial infarction within the past year
  • No uncontrolled hypertension
  • No high-risk uncontrolled arrhythmias

Other

  • Geriatric Depression Score < 12
  • No active uncontrolled infection
  • No active peptic ulcer
  • No uncontrolled diabetes mellitus
  • No inflammatory bowel disease
  • No history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80
  • No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent
  • No familial, social, geographical, or psychological condition that would preclude study follow-up
  • No definite contraindication to corticosteroids
  • No other serious illness or medical condition
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior or concurrent trastuzumab (Herceptin^®)

Chemotherapy

  • Prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed
  • More than 2 years since prior docetaxel or paclitaxel
  • No other concurrent chemotherapy

Endocrine therapy

  • No more than 1 prior hormonal therapy regimen for metastatic disease
  • At least 10 days since prior hormonal therapy
  • No concurrent hormonal therapy

  • No concurrent chronic corticosteroids

    • Concurrent low-dose corticosteroids (≤ 20 mg/day of methylprednisolone or equivalent) allowed provided treatment was initiated > 6 months before study entry

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 30 days since prior active treatment on another clinical trial
  • Concurrent bisphosphonates allowed for bone metastases, osteoporosis, or osteopenia
  • No other concurrent anticancer therapy
  • No other concurrent investigational drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Toxicity
Response rate
Progression-free survival
Overall survival
Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale
Mood status as measured by the Geriatric Depression Scale

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Study Chair: Suzette Delaloge, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimate)

March 4, 2005

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 2, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000417747
  • FRE-FNCLCC-GERICO-04/0406
  • EU-20504

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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