NCT00026078

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel and ifosfamide in treating women who have metastatic breast cancer.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Geographic Reach
2 countries

8 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

August 7, 2013

Status Verified

November 1, 2006

First QC Date

November 9, 2001

Last Update Submit

August 6, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

Secondary Outcomes (5)

  • Time to treatment failure

  • Duration of response

  • Survival

  • Toxicity as assessed by CTC version 2.0

  • Quality of life as assessed by Schipper's Functional Living Index - Cancer

Interventions

docetaxelDRUG
ifosfamideDRUG

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic breast cancer * Bidimensionally measurable lesions * The following are not considered measurable: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Inflammatory breast disease * Lymphangitis cutis/pulmonis * Disease progression after hormonal therapy allowed provided at least 1 month since last therapeutic manipulation * No CNS metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 21 to 75 Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 OR * Zubrod 0-2 Life expectancy: * More than 12 weeks Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 11 g/dL Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * SGOT no greater than 1.25 times ULN Renal: * Creatinine clearance at least 60 mL/min Cardiovascular: * No history of congestive heart failure * No myocardial infarction within the past 6 months * No active ischemic heart disease * No uncontrolled hypertension Other: * Not pregnant * No other prior or concurrent malignancy except properly treated basal cell skin cancer or carcinoma in situ of the cervix * No other medical or psychiatric diseases that would preclude study * No geographical situation that would preclude study * No history of alcohol abuse PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior adjuvant chemotherapy including ifosfamide or docetaxel * No prior systemic chemotherapy for metastatic breast cancer Endocrine therapy: * See Disease Characteristics * No concurrent corticoids, gestagens, or androgens unless strictly indicated Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent drinks containing caffeine or alcohol

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

Sponsors & Collaborators

Study Sites (8)

Grupo Oncologico Cooperativo del Sur

Bahía Blanca, Buenos Aires, 8000, Argentina

RECRUITING

Policlinica Privada Instituto De Medicina Nuclear

Bahía Blanca, Buenos Aires, 8000, Argentina

RECRUITING

St. Joseph Medical Center

Manuel B. Gonnet, Buenos Aires, 1987 MB, Argentina

RECRUITING

Sanatorio Santa Rosa S.R.L.

Santa Rosa, La Pampa Province, 6300, Argentina

RECRUITING

Unidad Oncologica Del Neuquen

Neuquén, Neuquén Province, Argentina

RECRUITING

C.R I O.

Mar del Plata, 7600, Argentina

RECRUITING

Centro Oncologico Tres Arroyos

Tres Arroyos, 7500, Argentina

RECRUITING

Centro Medico Nacional de Occidente

Guadalajara, Jalisco, 4430, Mexico

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelIfosfamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bernardo A. Leone, MD

    Unidad Oncologica Del Neuquen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2001

First Posted

January 27, 2003

Study Start

March 1, 2001

Last Updated

August 7, 2013

Record last verified: 2006-11

Locations

ME(1)AR(7)