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Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer

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)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006381
Enrollment
Unknown
Registered
2003-01-27
Start date
2000-06-30
Completion date
2004-02-29
Last updated
2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer

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.

Detailed 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.

Interventions

BIOLOGICALtrastuzumab
DRUGcelecoxib

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026