Biomarkers in Women Receiving Chemotherapy & Celecoxib for Stage II or Stage III Breast Cancer Removable by Surgery

NCT00665457 | Terminated Phase 2 Results DMC

• 2 other identifiers: 0085-04-FBP30CA036727
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This phase II clinical trial is studying biomarkers and side effects in women receiving chemotherapy and celecoxib for stage II or stage III breast cancer that can be removed by surgery.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Grade 4 Adverse Events

  Grading of adverse events was determine by the principal investigator according to NCI common toxicity criteria (CTC version 3.0). Safety analysis is based on any participant experiencing a grade 4 AE.

  every 3 weeks X 4, then every 2 weeks X4

• Participants Who Experienced Pathologic Complete Response, Progression-free and Overall Survival, and Time to Treatment Failure

  CTEP RECIST guidelines are defined as followed: Pathologic complete response is no signs of residual malignancy cells at the primary site and axillary lymph nodes are seen with histologic examination. Progression-free survival is defined as from the first date of therapy until the first notation of clinical progression or relapse. Overall survival is defined as from the first date of therapy until the date of death. Time to treatment failure is defined as from the first date of therapy until the date the patient is removed from study for any reason.

  20 weeks

Study Arms (1)

Celecoxib

EXPERIMENTAL

•Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery. •Surgery: Patients undergo definitive surgery (either modified radical mastectomy or lumpectomy combined with axillary node dissection). Patients may also undergo adjuvant radiotherapy and hormonal therapy at the discretion of multidisciplinary breast team.

Biological: filgrastim; Drug: capecitabine; Drug: celecoxib; Drug: cyclophosphamide; Drug: docetaxel; Drug: doxorubicin hydrochloride; Genetic: gene expression analysis; Genetic: polymorphism analysis; Genetic: protein expression analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: imaging biomarker analysis; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: pharmacogenomic studies; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Procedure: needle biopsy; Procedure: neoadjuvant therapy; Procedure: radiomammography; Procedure: ultrasound imaging

Interventions

filgrastim BIOLOGICAL

Also known as: Neupogen

Celecoxib

capecitabine DRUG

Also known as: Xeloda

Celecoxib

celecoxib DRUG

Also known as: Celebrex

Celecoxib

cyclophosphamide DRUG

Also known as: Cytoxan, Neosar

Celecoxib

docetaxel DRUG

Also known as: Docefrez, Taxotere

Celecoxib

doxorubicin hydrochloride DRUG

Also known as: Lipodox, Lipodox 50, and Doxil

Celecoxib

gene expression analysis GENETIC

Celecoxib

polymorphism analysis GENETIC

Celecoxib

protein expression analysis GENETIC

Celecoxib

reverse transcriptase-polymerase chain reaction GENETIC

Celecoxib

imaging biomarker analysis OTHER

Celecoxib

immunohistochemistry staining method OTHER

Celecoxib

laboratory biomarker analysis OTHER

Celecoxib

pharmacogenomic studies OTHER

Celecoxib

dynamic contrast-enhanced magnetic resonance imaging PROCEDURE

Celecoxib

needle biopsy PROCEDURE

Celecoxib

neoadjuvant therapy PROCEDURE

Celecoxib

radiomammography PROCEDURE

Celecoxib

ultrasound imaging PROCEDURE

Celecoxib

Eligibility Criteria

• Age: 19 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologic evidence of invasive breast cancer
• Stage II-III disease
• Resectable disease
• Must have a primary tumor estimated by mammogram, ultrasound or palpation to be ≥ 3 cm and/or palpable axillary nodes \> 1 cm for whom neoadjuvant chemotherapy is appropriate
• ECOG performance status 0-1
• Absolute granulocyte count \> 2,000/mm\^3
• Platelet count \> 100,000/mm\^3
• Serum bilirubin \< 1.5 times upper limit of normal (ULN)
• Serum creatinine \< 1.5 times ULN
• Fertile patients must use effective contraception during and for 3 months after completion of study therapy
• At least 2 weeks since prior treatment with cyclooxygenase (COX)-2 inhibitors

You may not qualify if:

• Not pregnant or nursing/negative pregnancy test
• No allergies to sulfa medication, aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
• No uncontrolled concurrent illness that might jeopardize the patient's ability to receive the chemotherapy program outlined in this protocol, including any of the following:
• Active infection requiring intravenous antibiotics
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Serious, uncontrolled cardiac arrhythmia
• No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 years
• No prior chemotherapy or radiation therapy for ipsilateral breast cancer
• No concurrent sorivudine or brivudine to treat herpes simplex or herpes zoster viral infections
• No concurrent participation in another therapeutic clinical trial

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Filgrastim; Capecitabine; Celecoxib; Cyclophosphamide; Docetaxel; Doxorubicin; liposomal doxorubicin; Gene Expression Profiling; Amplified Fragment Length Polymorphism Analysis; Reverse Transcriptase Polymerase Chain Reaction; Immunohistochemistry; Pharmacogenomic Testing; Biopsy, Needle; Neoadjuvant Therapy; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Genetic Techniques; Investigative Techniques; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Genetic Testing; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Biopsy; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Combined Modality Therapy; Therapeutics; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Results Point of Contact

• Title: Elizabeth Reed, M.D.
• Organization: University of Nebraska Medical Center

ereed@unmc.edu

402-559-5388

Study Officials

• Elizabeth C. Reed, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 23, 2008
• Study Start: April 15, 2004
• Primary Completion: July 31, 2009
• Study Completion: July 31, 2009
• Last Updated: September 13, 2023
• Results First Posted: July 10, 2018

Record last verified: 2023-08

Locations

US (1)