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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
celecoxib
vinorelbine ditartrate
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage IV breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 9, 2004
Last Updated
July 23, 2020
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00075673
Brief Title
Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Study Start Date
November 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
recurrent breast cancer, stage IV breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Description
Patients receive oral celecoxib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
vinorelbine ditartrate
Intervention Description
Patients receive oral vinorelbine on days 7, 14, and 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Silverman, MD
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5055
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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