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Docetaxel in Treating Older Women With Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
docetaxel
quality-of-life assessment
Sponsored by
UNICANCER
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  • Institut Curie Hopital
  • Centre Henri Becquerel
  • C.H. Senlis
  • Institut Gustave Roussy
  • Istituto Nazionale Di Riposo e Cura per Anziani
  • Clinique De Genolier

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2005
Last Updated
September 2, 2013
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00104624
Brief Title
Docetaxel in Treating Older Women With Metastatic Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Toxicity issues
Study Start Date
May 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Response rate
Title
Overall survival
Title
Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale
Title
Progression-free survival
Title
Mood status as measured by the Geriatric Depression Scale
Title
Toxicity

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzette Delaloge
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Istituto Nazionale Di Riposo e Cura per Anziani
City
Rome
ZIP/Postal Code
00189
Country
Italy
Facility Name
Clinique De Genolier
City
Genolier
ZIP/Postal Code
Ch-1272
Country
Switzerland

12. IPD Sharing Statement

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Docetaxel in Treating Older Women With Metastatic Breast Cancer

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