Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI, Pharmaceutical / Industry CWRU-ICC-3102 GSK-CWRU-ICC-3102, NCT00075673

Objectives

1. Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer.
2. Determine the safety profile of this regimen in these patients.

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

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 H₂ blocking agents or proton pump inhibitors allowed for the treatment of dyspepsia or gastroesophageal reflux disease
• Concurrent bisphosphonates allowed

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/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

A total of 12-18 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Beth Overmoyer, MD, FACP, Principal investigator		Ph: 216-844-8573 Email: bao4@po.cwru.edu

Registry Information
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
Trial Start Date		2003-11-05
Registered in ClinicalTrials.gov		NCT00075673
Date Submitted to PDQ		2003-12-02
Information Last Verified		2004-11-04
NCI Grant/Contract Number		P30-CA43703

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