NCT00006108

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel, and trastuzumab in treating patients who have metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2001

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

February 26, 2004

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

2.1 years

First QC Date

August 3, 2000

Last Update Submit

February 3, 2012

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

trastuzumabBIOLOGICAL
capecitabineDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Metastatic disease HER2 overexpressing tumor (2+ or 3+) Bidimensionally measurable or evaluable disease Hormone receptor status: Estrogen receptor positive or negative PATIENT CHARACTERISTICS: Age: 18 to 59 Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Ejection fraction at least 50% by MUGA No history of congestive heart failure No uncontrolled cardiac arrhythmias Other: No other prior malignancy except squamous cell or basal cell carcinoma of the skin, noninvasive ductal carcinoma of the breast, or cervical dysplasia No prior motor or sensory neuropathy grade 2 or higher Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior trastuzumab (Herceptin) No concurrent hematopoietic growth factors Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant chemotherapy allowed (including regimens containing doxorubicin) No prior paclitaxel, 24 hour infusion fluorouracil, or capecitabine Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to 50% or more of the bone marrow Surgery: Not specified Other: No other concurrent experimental drugs

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

Sponsors & Collaborators

Study Sites (1)

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TrastuzumabCapecitabinePaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Frances A. Collichio, MD

    UNC Lineberger Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2000

First Posted

February 26, 2004

Study Start

August 1, 1999

Primary Completion

September 1, 2001

Study Completion

July 1, 2002

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations

US(1)