Breast Cancer Clinical Trial

Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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 for people with:

Breast Cancer

Phase:

Phase 2

Study ID:

NCT00006381

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Study ID:

NCT00006381

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

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