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

NCT00075673 | Terminated Phase 1 DMC

• 1 other identifier: ICC3102
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

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

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

Interventions

celecoxib DRUG

Patients receive oral celecoxib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

vinorelbine ditartrate DRUG

Patients receive oral vinorelbine on days 7, 14, and 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

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

Cleveland, Ohio, 44106-5055, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Celecoxib; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Paula Silverman, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2004
• First Posted: January 12, 2004
• Study Start: November 1, 2003
• Primary Completion: September 1, 2004
• Study Completion: February 1, 2005
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

US (1)