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Home > "V" Clinical Trials Conditions > Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer  Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BethOvermoyer, Principal Investigator, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5055
United States
Recruiting Beth Overmoyer 216-844-3862
Additional Information:
Study ID Numbers: CDR0000347413; GSK-CWRU-ICC-3102,CWRU-ICC-3102
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075673
Other Stage 4 Breast Cancer Studies:
1. Vaccine Therapy in Treating Women With Metastatic Breast Cancer
2. Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement
3. Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer
4. Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
5. Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Ohio Clinical Trials
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Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
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