Docetaxel in Treating Older Women With Metastatic Breast Cancer

NCT00104624 | Terminated Phase 2

• 3 other identifiers: CDR0000417747FRE-FNCLCC-GERICO-04/0406EU-20504
• Study Type: interventional
• Target: 53
• Locations: 3 countries
• Sites: 7

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Interventions

docetaxel DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (7)

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

Marseille, 13273, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Istituto Nazionale Di Riposo e Cura per Anziani

Rome, 00189, Italy

Location

Clinique De Genolier

Genolier, Ch-1272, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Suzette Delaloge

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: May 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2008
• Last Updated: September 4, 2013

Record last verified: 2013-09

Locations

FR (5); IT (1); CH (1)