NCT00006381

Brief Summary

RATIONALE: Celecoxib may be effective in preventing the further development of cancer. 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 trastuzumab with celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and trastuzumab in treating women who have metastatic breast cancer that has not responded to previous trastuzumab.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2000

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

June 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

December 19, 2013

Status Verified

December 1, 2003

First QC Date

October 4, 2000

Last Update Submit

December 18, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

trastuzumabBIOLOGICAL
celecoxibDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven metastatic breast cancer * HER2/neu-positive (overexpressing) tumor tissue * Failed prior trastuzumab (Herceptin) therapy with or without chemotherapy * Resected stage IV disease allowed if evidence of disease * Bidimensionally measurable or evaluable disease * No lesions in previously irradiated field except nonbone lesions progressive after radiotherapy * No pleural effusions * No blastic or mixed bony metastases * No palpable abdominal masses * No leptomeningeal disease * Brain metastases allowed if: * No concurrent use of steroids * At least 3 months since prior brain irradiation * No evidence of progression of metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Karnofsky 70-100% Life expectancy: * At least 3 months Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Hemoglobin at least 8.0 g/dL * Platelet count at least 100,000/mm\^3 Hepatic: * AST/ALT no greater than 2 times upper limit of normal (ULN) * Bilirubin no greater than 1.5 times ULN Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * LVEF at least 50% Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective barrier contraception * No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer * No other serious medical illness * No severe infection * No severe malnutrition * No prior allergic reactions to sulfonamides or celecoxib PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * Prior trastuzumab (Herceptin) for breast cancer allowed, either as adjuvant/neoadjuvant or for metastatic disease Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Prior cytotoxic therapy for breast cancer allowed, either as adjuvant/neoadjuvant or for metastatic disease Endocrine therapy: * See Disease Characteristics * At least 3 weeks since prior hormonal therapy * Prior exogenous hormonal therapy for stage IV disease and/or as adjuvant therapy allowed Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * Prior localized radiotherapy allowed if no influence on the signal measurable lesion * Concurrent localized radiotherapy allowed if no influence on the signal measurable lesion Surgery: * See Disease Characteristics * At least 3 weeks since prior major surgery and recovered * At least 2 weeks since prior minor surgery and recovered

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TrastuzumabCelecoxib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Chau T. Dang, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2000

First Posted

January 27, 2003

Study Start

June 1, 2000

Study Completion

February 1, 2004

Last Updated

December 19, 2013

Record last verified: 2003-12

Locations

US(1)