NCT00002627

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells, allowing higher doses of chemotherapy to be used. PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel when added to high-dose combination chemotherapy followed by peripheral stem cell transplantation in treating women with breast cancer at high risk of relapse.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

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

November 1, 1994

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

July 29, 2004

Completed
Last Updated

January 10, 2014

Status Verified

July 1, 2000

First QC Date

November 1, 1999

Last Update Submit

January 9, 2014

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancerstage IIIB breast cancerinflammatory breast cancer

Interventions

filgrastimBIOLOGICAL
carboplatinDRUG
cyclophosphamideDRUG
mesnaDRUG
paclitaxelDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically diagnosed adenocarcinoma of the breast of the following stages: Stage II/IIIA disease with 4 or more involved axillary lymph nodes Stage IIIB Inflammatory No bone marrow involvement documented on bone marrow aspiration and biopsy Prior breast cancer allowed Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Women only Menopausal status: Not specified Performance status: Karnofsky 70%-100% Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 50% by MUGA No abnormal cardiac conduction documented as second- or third-degree heart block or bundle branch block Pulmonary: DLCO at least 60% of predicted Other: Not HIV positive No history of second malignancy within 5 years except: Nonmelanomatous skin cancer In situ carcinoma of the cervix No pregnant women PRIOR CONCURRENT THERAPY: At least 3 courses of induction therapy required, with regimen at the discretion of the investigator No disease progression during induction

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

Sponsors & Collaborators

Study Sites (1)

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsInflammatory Breast Neoplasms

Interventions

FilgrastimCarboplatinCyclophosphamideMesnaPaclitaxelPeripheral Blood Stem Cell Transplantation

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 CompoundsAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicSulfhydryl CompoundsSulfur CompoundsSulfonic AcidsSulfur AcidsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Paul J. Petruska, MD

    St. Louis University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 29, 2004

Study Start

November 1, 1994

Last Updated

January 10, 2014

Record last verified: 2000-07

Locations

US(1)