Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00075673
First received: January 9, 2004
Last updated: July 21, 2011
Last verified: July 2011

January 9, 2004
July 21, 2011
November 2003
September 2004   (final data collection date for primary outcome measure)
Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer. [ Time Frame: Courses (21 days) repeat every 21 days in the absence of disease progression or unacceptable toxicity. ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00075673 on ClinicalTrials.gov Archive Site
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Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
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

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: celecoxib
    Patients receive oral celecoxib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Drug: vinorelbine ditartrate
    Patients receive oral vinorelbine on days 7, 14, and 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
February 2005
September 2004   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00075673
ICC3102, P30CA043703, CWRU-ICC-3102, GSK-CWRU-ICC-3102
Yes
Paula Silverman, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Paula Silverman, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP