Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
Breast Cancer

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage IV breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Recurrent or metastatic (stage IV) disease Incurable disease Measurable or evaluable disease Stable brain metastases allowed Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Not specified Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL Hepatic Bilirubin normal AST/ALT ≤ 2.5 times upper limit of normal Renal Creatinine normal OR Creatinine clearance ≥ 60 mL/min No clinically significant proteinuria No impaired renal function Cardiovascular No symptomatic congestive heart failure No unstable angina No cardiac arrhythmia No inadequately controlled hypertension Gastrointestinal No disorder that would alter gastrointestinal motility or absorption No dysphagia Able to swallow tablets or capsules Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No hypersensitivity to celecoxib No prior urticaria, asthma, or other allergic-type reaction after taking aspirin or other nonsteroidal anti-inflammatory drugs No allergy to sulfa No other concurrent uncontrolled illness No psychiatric illness or social situation that would preclude study compliance No ongoing or active infection PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 weeks since prior trastuzumab (Herceptin®) and recovered No concurrent hematopoietic growth factors Chemotherapy At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Prior adjuvant or neoadjuvant chemotherapy allowed Prior chemotherapy for recurrent or metastatic disease allowed No prior vinorelbine Endocrine therapy At least 2 weeks since prior hormonal therapy Prior adjuvant or neoadjuvant hormonal therapy allowed Prior hormonal therapy for recurrent or metastatic disease allowed Radiotherapy At least 4 weeks since prior radiotherapy for metastatic disease Prior adjuvant radiotherapy allowed Surgery Not specified Other At least 3 weeks since prior investigational anticancer agents and recovered At least 1 week since prior cyclooxygenase-2 (COX-2) inhibitors, except celecoxib No concurrent administration of any of the following drugs: Lithium Fluconazole Aluminum antacids Magnesium antacids Concurrent H_2 blocking agents or proton pump inhibitors allowed for the treatment of dyspepsia or gastroesophageal reflux disease Concurrent bisphosphonates allowed
Sites / Locations
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center