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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


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer.

Outcome Time Frame:

Courses (21 days) repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Safety Issue:

Yes

Principal Investigator

Paula Silverman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

ICC3102

NCT ID:

NCT00075673

Start Date:

November 2003

Completion Date:

February 2005

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065