Expired Study
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New York, New York 10021


Purpose:

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.


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


NCT ID:

NCT00006381


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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