NCT00004172

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to compare the effectiveness of two regimens of chemotherapy and filgrastim plus stem cell transplantation in treating patients who have previously untreated stage III or stage IV breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1999

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 1999

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
12 months until next milestone

First Posted

Study publicly available on registry

September 16, 2004

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

4 years

First QC Date

December 10, 1999

Last Update Submit

June 8, 2012

Conditions

Breast Cancer

Keywords

stage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage IIIB breast cancer

Interventions

filgrastimBIOLOGICAL
carboplatinDRUG
cyclophosphamideDRUG
ifosfamideDRUG
thiotepaDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven previously treated stage III or IV breast cancer No CNS disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Physiologic 65 and under Menopausal status: Not specified Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Hepatic function normal unless due to liver metastases Bilirubin less than 1.5 times normal SGOT or SGPT less than 1.5 times normal Alkaline phosphatase less than 1.5 times normal If hepatitis C antibody positive, then liver function must be normal OR liver dysfunction must be due to metastatic disease and not chronic hepatitis Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF normal No myocardial infarction within past 6 months No significant arrhythmia requiring medications No history of congestive heart failure Pulmonary: DLCO at least 50% predicted FEV1 and/or FVC at least 75% predicted No serious nonneoplastic pulmonary disease (severe chronic obstructive lung disease) that would preclude study therapy Other: Not pregnant Negative pregnancy test HIV negative Hepatitis B and C surface antigen negative No active serious medical condition that would preclude study therapy PRIOR CONCURRENT THERAPY: See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FilgrastimCarboplatinCyclophosphamideIfosfamideThiotepaPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTriethylenephosphoramideAziridinesAzirinesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Jane N. Winter, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

September 16, 2004

Study Start

October 1, 1999

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations

US(1)