Expired Study
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New York, New York 10021


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.

Study summary:

OBJECTIVES: - Determine the efficacy of celecoxib and trastuzumab (Herceptin) in women with HER2/neu-overexpressing metastatic breast cancer that is refractory to prior trastuzumab. - Determine the safety of celecoxib in these patients. OUTLINE: At least 3 weeks after the last dose of prior chemotherapy, patients receive oral celecoxib twice daily. Patients continue or restart trastuzumab (Herceptin) IV over 30-90 minutes weekly or every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within approximately 9 months.


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

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer

Official Title:

Phase II Study of Celecoxib in HER-2/Neu Overexpressing Metastatic Breast Cancer Patients Who Have Failed Recombinant Humanized Anti-p 185HER Monoclonal Antibody Trastuzumab (HERCEPTIN)

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Chau T. Dang, MD
Study Chair
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:June 2000
Completion Date:February 2004
Completion Type:Actual
Verification Date:December 2003
Last Changed Date:December 18, 2013
First Received Date:October 4, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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