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
18 Years
N/A
Female
Breast Cancer
Trial Information
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
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.
OUTLINE: This is a dose-escalation study.
Patients receive oral celecoxib twice daily on days 1-21 and oral vinorelbine on days 7, 14,
and 21. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity.
Cohorts of 3-6 patients receive escalating doses of celecoxib and vinorelbine until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer.
Outcome Time Frame:
Courses (21 days) repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Safety Issue:
Yes
Principal Investigator
Paula Silverman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
ICC3102
NCT ID:
NCT00075673
Start Date:
November 2003
Completion Date:
February 2005
Related Keywords:
- Breast Cancer
- recurrent breast cancer
- stage IV breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
