Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
This study has been terminated.
Sponsor:
Case Comprehensive Cancer Center
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: celecoxib Drug: vinorelbine ditartrate |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 6 |
| Study Start Date: | November 2003 |
| Study Completion Date: | February 2005 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075673
Locations
| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5055 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Principal Investigator: | Paula Silverman, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Paula Silverman, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00075673 History of Changes |
| Other Study ID Numbers: | ICC3102, P30CA043703, CWRU-ICC-3102, GSK-CWRU-ICC-3102 |
| Study First Received: | January 9, 2004 |
| Last Updated: | July 21, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
recurrent breast cancer stage IV breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Vinorelbine Vinblastine Celecoxib Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013