Clinical trial · Interventional
Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
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
NCT00075673CI-TRIAL-00046212terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vinorelbine with celecoxib may kill more tumor cells. PURPOSE: Phase I trial to determine the effectiveness of combining vinorelbine with celecoxib in treating women who have relapsed or metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| vinorelbine ditartrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer.
- timeFrame
- Courses (21 days) repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.