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Sponsors and Collaborators: |
University of Arkansas Genentech |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00203502 |
The main purpose of this study is to find out what effects taking the drug bevacizumab together with two chemotherapeutic agents, docetaxel and cyclophosphamide followed by doxorubicin alone before surgery will on breast cancer. Bevacizumab will be given for twelve weeks in combination with chemotherapy then it ill be held during the administration of doxorubicin. Twenty-eight to fifty-six days after undergoing surgery, all patients will receive nine three-weekly infusions of bevacizumab.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Bevacizumab/Avastin Drug: Cyclophosphamide Drug: Doxorubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Primary Systemic Therapy Using Sequential Docetaxel/Cyclophosphamide/Bevacizumab Followed by Doxorubicin in Operable/Locally Advanced Breast Cancer |
Enrollment: | 40 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Prior to being enrolled in this study, they will undergo an evaluation to determine eligibility. The study doctor will obtain a complete medical history, complete a physical examination including blood pressure and heart rate. The doctor will also obtain a baseline ECG as well as blood tests (approximately two tablespoons of blood). In order to decrease the effects of food, exercise and the sleep/wake cycle variability, all blood samples must be taken between 8AM - 10AM and patients will need to fast (no food or drink) for 10 hours prior to the blood test. Patients will also need to strain from working out prior to the blood test. The study will ask for a list of current medications. Patients will not be eligible if they have a history of or now require long-term anticoagulant (blood thinner) therapy (i.e. Coumadin or anything patients may be taking to prevent blood clots) have an allergy to bevacizumab or any other drugs used in the study.
Many of the following evaluations are commonly done to determine diagnosis and/or stage of breast cancer and may have already had some of all of them done. If the following procedures were not done within three weeks, they will need to be done again prior to receiving any study therapy.
All study participants will be treated with bevacizumab 15 mg/kg plus docetaxel 75 mg/m2 and cyclophosphamide 500 mg/m2 every three weeks for a total of four treatments. Three weeks after the completion of this part of the treatment patients will start receiving doxorubicin 60 mg/m2 every three weeks for a total of four treatments. All these drugs will be given as intravenous infusion on the first day of each three-week period.
Patients will come in for every three week visits and have a physical exam including blood pressure and heart rate. Medications lists will be taken and any side effects that may have been experienced. Tumor caliper measurements will be done and blood will be drawn at each of these visits.
A mammogram and MUGA scan will be done again just prior to surgery. Patients will undergo tumor surgery approximately six months after treatment.
Patients will need to visit the study physician one month after surgery for another physical examination including blood pressure and heart rate, an assessment of any side effects and a list of current medications.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 |
Principal Investigator: | Issam Makhoul, MD | University of Arkansas |
Responsible Party: | University of Arkansas for Medical Sciences ( Chris Golden ) |
Study ID Numbers: | UARK 2004-59 |
Study First Received: | September 12, 2005 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00203502 History of Changes |
Health Authority: | United States: Institutional Review Board |
Operable and Locally advanced Breast Cancer |
Skin Diseases Immunologic Factors Breast Neoplasms Cyclophosphamide Bevacizumab Angiogenesis Inhibitors Immunosuppressive Agents |
Doxorubicin Docetaxel Anti-Bacterial Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Bevacizumab Antibiotics, Antineoplastic Angiogenesis Inhibitors Immunosuppressive Agents |
Doxorubicin Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |