NCT00010075

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

July 24, 2008

Status Verified

June 1, 2003

First QC Date

February 2, 2001

Last Update Submit

July 23, 2008

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

fluorouracilDRUG
leucovorin calciumDRUG
mitoxantrone hydrochlorideDRUG

Eligibility Criteria

Age75 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the breast * Bidimensionally measurable or evaluable disease * At least one non-irradiated lesion that is at least 2 cm in the greater diameter OR * Serous drainage, cutaneous metastasis, osseous metastasis, etc. * No symptomatic cerebral metastasis * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 75 to 90 Sex: * Female Menopausal status: * Postmenopausal Performance status: * WHO 0-2 Life expectancy: * At least 3 months Hematopoietic: * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 Hepatic: * Alkaline phosphatase less than 3 times normal * Bilirubin less than 1.5 times normal * Transaminases less than 3 times normal * Total protein greater than 60% * Albumin greater than 30 g/L Renal: * Creatinine clearance greater than 60 mL/min Cardiovascular: * LVEF greater than 50% by echocardiogram or scintigraph * ECG normal * No uncontrolled angina * No myocardial infarction within past 6 months Other: * No other medical illness or condition that would preclude study * No other prior malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the cervix * No psychological, social, familial, or geographical reasons that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior adjuvant chemotherapy allowed * No prior adjuvant anthracyclines * No prior chemotherapy for metastatic disease Endocrine therapy: * One or two prior regimens of hormonal therapy allowed for metastatic disease Radiotherapy: * No prior radiotherapy for metastatic disease Surgery: * Not specified Other: * No concurrent participation in another study

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

Sponsors & Collaborators

Study Sites (6)

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Polyclinique De Courlancy

Metz, 55038, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Centre Medico-Chirurgical Foch

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FluorouracilLeucovorinMitoxantrone

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic Compounds

Study Officials

  • Elisabeth Carola, MD

    C.H. Senlis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2001

First Posted

January 27, 2003

Study Start

January 1, 2000

Last Updated

July 24, 2008

Record last verified: 2003-06

Locations

FR(6)