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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


Phase 2
70 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

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

Safety Issue:

No

Principal Investigator

Suzette Delaloge

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

United States: Federal Government

Study ID:

CDR0000417747

NCT ID:

NCT00104624

Start Date:

December 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

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