Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075673
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: celecoxib
Drug: vinorelbine ditartrate
Phase I

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Vinorelbine Vinorelbine tartrate Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2003
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075673

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5055
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Principal Investigator: Beth A. Overmoyer, MD, FACP Case Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000347413, CWRU-ICC-3102, GSK-CWRU-ICC-3102
Study First Received: January 9, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00075673  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IV breast cancer

Study placed in the following topic categories:
Vinorelbine
Celecoxib
Skin Diseases
Breast Neoplasms
Vinblastine
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Tubulin Modulators
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 13, 2009