E2104 TRIAL OF AVASTIN DD ADRIAMYCIN AND CYTOXAN FOLLOWED BY TAXOL IN LYMPH NODE

E2104 阿瓦斯汀 DD 阿霉素和环磷酰胺随后在淋巴结中使用紫杉醇的试验

• 批准号: 7603255
• 负责人: CARLA I FALKSON
• 金额: $ 1.27万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603255
• 关键词: Adriamycin PFS; Avastin; Blood Vessels; Computer Retrieval of Information on Scientific Projects Database; Consent; Cyclophosphamide; Dose; Doxorubicin; Funding; Goals; Grant; Hour; Institution; Newly Diagnosed; Paclitaxel; Participant; Patients; Pharmaceutical Preparations; Phase II Clinical Trials; Purpose; Randomized; Research; Research Personnel; Resources; Source; United States National Institutes of Health; Upper arm; Veins; Week; bevacizumab; chemotherapy; day; heart function; lymph nodes; malignant breast neoplasm

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This randomized phase II study has an accrual goal of 200 participants and we anticipate 15 to 30 here at UAB. It is unknown how to best use Bevacizumab in combination with chemotherapy for patients with newly diagnosed breast cancer. The purpose of this study is to examine whether the use of bevacizumab along with chemotherapy drugs commonly used in treating newly diagnosed patients with breast cancer (in this study doxorubicin and cytoxan) is safe. Specifically, this study will determine if adding bevacizumab increases the effect of chemotherapy on heart function. Eligible consents participants will be randomized to one of the following arms: Group A - Participants will receive Adriamycin¿, Cytoxan¿ (AC) and bevacizumab (an investigational agent that inhibits the formation of blood vessels) by vein over about one hour one day every two weeks for a total of 4 treatments. After all treatment with AC plus bevacizumab is done, participants will receive Taxol¿ and bevacizumb by vein over about 3-4 hours every two weeks for 4 treatments. After all treatment with Taxol¿ plus bevacizumab is done, participants will receive bevacizumab by vein over about 30 minutes one day every two weeks for a total of 18 treatments. The first dose of bevacizumab will be given over about 90 minutes. Group B - Participants will receive Adriamycin¿, Cytoxan¿ (AC) by vein over about 30 minutes one day every two weeks for a total of 4 treatments. After all treatment with AC is done, a participant will receive Taxol¿ and bevacizumab (an investigational agent that inhibits the formation of blood vessels) by vein over about 3-4 hours every two weeks for 4 treatments. After all treatment with Taxol¿ plus bevacizumab is done, a participant will receive bevacizumab by vein over about 30 minutes one day 1 every two weeks for a total of 22 treatments. The first dose of bevacizumab will be given over about 90 minutes. If a participant does well with the first dose, the second dose will be given over one hour. If a participant does well with the second dose, other doses of bevacizumab will be given over about 30 minutes.

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项随机II期研究的累积目标是200名参与者，我们预计UAB将有15至30名参与者。 目前尚不清楚如何最好地使用贝伐单抗联合化疗的新诊断的乳腺癌患者。本研究的目的是检查贝伐珠单抗沿着化疗药物（在本研究中为阿霉素和环磷酰胺）治疗新诊断的乳腺癌患者是否安全。具体来说，这项研究将确定是否添加贝伐单抗增加化疗对心脏功能的影响。 合格的知情同意受试者将被随机分配至以下组之一： A组-受试者将接受阿霉素、环磷酰胺（AC）和贝伐单抗（一种抑制血管形成的研究药物）静脉给药，每两周一天，每次约1小时，共4次治疗。在AC加贝伐珠单抗的所有治疗完成后，受试者将接受泰素和贝伐珠单抗静脉给药，每两周约3-4小时，共4次治疗。在所有泰素加贝伐单抗治疗完成后，参与者将接受贝伐单抗静脉注射，每两周一天，每次约30分钟，共18次治疗。贝伐珠单抗的第一剂将在约90分钟内给予。 B组-受试者将接受阿霉素、环磷酰胺（AC）静脉给药，每两周一次，每次约30分钟，共4次治疗。在所有AC治疗完成后，受试者将接受泰素和贝伐单抗（一种抑制血管形成的研究药物）静脉给药，每两周约3-4小时，共4次治疗。在所有泰素加贝伐珠单抗治疗完成后，受试者将接受贝伐珠单抗静脉给药约30分钟，每两周一次，共22次治疗。贝伐珠单抗的第一剂将在约90分钟内给予。 如果受试者在第一次给药时表现良好，则将在一小时内给予第二次给药。如果受试者在第二次给药时表现良好，则将在约30分钟内给予其他剂量的贝伐珠单抗。