NCT00002628

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 drug may kill more tumor cells. 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 added to a regimen of high-dose chemotherapy with cyclophosphamide and carboplatin followed by peripheral stem cell transplantation in treating women with metastatic breast cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Geographic Reach
1 country

3 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

November 1, 1994

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2004

Completed
Last Updated

January 10, 2014

Status Verified

April 1, 2000

First QC Date

November 1, 1999

Last Update Submit

January 9, 2014

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent 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, stage IV adenocarcinoma of the breast Previously untreated or prior adjuvant chemotherapy only CR or PR following 3-5 courses of induction chemotherapy for current diagnosis with one of the following: Cyclophosphamide/doxorubicin Cyclophosphamide/methotrexate/fluorouracil Cyclophosphamide/mitoxantrone No active CNS metastases on CT or MRI Hormone receptor status: Any status PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Women Menopausal status: Pre- or postmenopausal Performance status: ECOG 0-2 Hematopoietic: WBC greater than 3,000 Platelets greater than 100,000 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: Left ventricular ejection fraction greater than 50% on MUGA or echocardiogram No abnormal cardiac conduction on EKG, i.e.: No second- or third-degree heart block No bundle-branch block No arrhythmia except: Supraventricular sinus tachycardia Occasional premature atrial or ventricular contractions Pulmonary: DLCO greater than 60% of predicted Other: No preexisting peripheral neuropathy No HIV antibody No history of second malignancy within 5 years except: Nonmelanomatous skin cancer Cervical carcinoma in situ No pregnant or nursing women PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Hematologically recovered from prior chemotherapy Endocrine therapy: Failure on 1 prior hormonal regimen required for ER-positive disease (greater than 10 femtomoles) unless visceral metastatic crisis requires immediate chemotherapy Radiotherapy: Not specified Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (3)

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5265, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

Methodist Hospital-Central Unit

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

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

August 31, 2004

Study Start

November 1, 1994

Last Updated

January 10, 2014

Record last verified: 2000-04

Locations

US(3)