Status:
TERMINATED
Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE1
Brief Summary
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 c...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer. * Determine the safety profile of this regimen in these patients. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00075673
Start Date
November 1 2003
End Date
February 1 2005
Last Update
July 27 2020
Active Locations (1)
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1
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5055