Docetaxel in Treating Older Women With Metastatic Breast Cancer

NCT ID: NCT00104624

Last Updated: 2013-09-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2008-07-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Intervention Type: DRUG

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzette Delaloge

Role: STUDY_CHAIR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, , France

Institut Curie Hopital

Paris, , France

Centre Henri Becquerel

Rouen, , France

C.H. Senlis

Senlis, , France

Institut Gustave Roussy

Villejuif, , France

Istituto Nazionale Di Riposo e Cura per Anziani

Rome, , Italy

Clinique De Genolier

Genolier, , Switzerland

Countries

France; Italy; Switzerland

Other Identifiers

FRE-FNCLCC-GERICO-04/0406

Identifier Type: -

Identifier Source: secondary_id

EU-20504

Identifier Type: -

Identifier Source: secondary_id

CDR0000417747

Identifier Type: -

Identifier Source: org_study_id