Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: celecoxib (Drug); vinorelbine ditartrate (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Ireland Cancer Center Official(s) and/or principal investigator(s):
Beth A. Overmoyer, MD, FACP, Principal Investigator, Affiliation: Case Comprehensive Cancer Center
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 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.
Clinical Details
Official title: 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
Study design: Treatment
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Ireland Cancer Center, Cleveland, Ohio 44106-5055, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: November 2003
Last updated: May 23, 2008
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