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

July 23, 2020 updated by: Case Comprehensive Cancer Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5055
        • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Paula Silverman, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

January 9, 2004

First Submitted That Met QC Criteria

January 11, 2004

First Posted (Estimate)

January 12, 2004

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICC3102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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