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Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer



Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer

For Condition: recurrent breast cancer,stage 4 breast cancer
Status: Completed
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ChauDang,  Study Chair,  Memorial Sloan-Kettering Cancer Center

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


Additional Information:
Study ID Numbers:  CDR0000068255;  MSKCC-00078,NCI-G00-1869
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006381

Other Recurrent Breast Cancer Studies:
1. Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery

2. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery

3. Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy

4. Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy

5. Docetaxel in Treating Older Women With Metastatic Breast Cancer

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