A Phase I Study of Weekly Administration of Oral Navelbine in Combination With the COX-2 Inhibitor Celebrex in Relapsed and/or Metastatic Breast Cancer

Fecha de inicio: 1 de noviembre de 2003

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