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Sponsors and Collaborators: |
University of Nebraska National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00665457 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
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: mammography Procedure: needle biopsy Procedure: neoadjuvant therapy Procedure: ultrasound imaging |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Neoadjuvant Therapy and Biomarker Analysis of Stage II and III Breast Cancer With Docetaxel/Capecitabine and Celecoxib Followed by Doxorubicin/Cyclophosphamide and Celecoxib |
Estimated Enrollment: | 46 |
Study Start Date: | April 2004 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
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.
Blood is collected at baseline and examined for genetic polymorphisms associated with functional changes in proteins. Tumor tissue is obtained by needle biopsy at baseline, before the second course of docetaxel/capecitabine/celecoxib, and at surgical resection. Molecular markers and protein expression are assessed by immunohistochemistry using fluorescence-image analysis and real-time reverse-transcriptase PCR.
Patients undergo imaging comprising dynamic MRI, ultrasound, and mammogram at baseline and after the first and second 4 courses of chemotherapy.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologic evidence of invasive breast cancer
PATIENT CHARACTERISTICS:
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:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000583473, UNMC-08504 |
Study First Received: | April 22, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00665457 History of Changes |
Health Authority: | United States: Federal Government |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Antimetabolites Anti-Inflammatory Agents Capecitabine Celecoxib Skin Diseases Immunologic Factors Cyclooxygenase Inhibitors Breast Neoplasms Cyclophosphamide Immunosuppressive Agents Doxorubicin |
Docetaxel Anti-Bacterial Agents Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Docetaxel Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Alkylating Agents Breast Diseases Capecitabine Celecoxib Skin Diseases Cyclooxygenase Inhibitors Breast Neoplasms Enzyme Inhibitors Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Myeloablative Agonists Peripheral Nervous System Agents |