Docetaxel in Treating Older Women With Metastatic Breast Cancer

This study has been terminated.
(Toxicity issues)
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT00104624
First received: March 3, 2005
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Procedure: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Mood status as measured by the Geriatric Depression Scale [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 53
Study Start Date: May 2005
Study Completion Date: July 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104624

Locations
France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Institut Curie Hopital
Paris, France, 75248
Centre Henri Becquerel
Rouen, France, 76038
C.H. Senlis
Senlis, France, 60309
Institut Gustave Roussy
Villejuif, France, F-94805
Italy
Istituto Nazionale Di Riposo e Cura per Anziani
Rome, Italy, 00189
Switzerland
Clinique De Genolier
Genolier, Switzerland, Ch-1272
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Suzette Delaloge Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Additional Information:
No publications provided

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00104624     History of Changes
Other Study ID Numbers: CDR0000417747, FRE-FNCLCC-GERICO-04/0406, EU-20504
Study First Received: March 3, 2005
Last Updated: September 2, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UNICANCER:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014