Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer (SCLC): A Safety, Feasibility and Efficacy Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 17
- 主要终点
- To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC).
研究概览
简要总结
Improvements in therapy for relapsed SCLC are much needed. Paclitaxel has been previously tested and found to have significant single agent activity in relapsed SCLC, including in refractory patients. Angiogenesis plays an important role in SCLC, increased VEGF levels are associated with worse outcomes. Bevacizumab, a monoclonal antibody to VEGF, increase response rates and survival when combined with chemotherapy agents compared with the chemotherapy agent alone in NSCLC, breast cancer, and colorectal cancer. Paclitaxel plus bevacizumab, in the dose and schedule proposed in this study, improves response rates and progression free survival compared with paclitaxel alone in women with metastatic breast cancer. Therefore, we will be testing the safety, feasibility, and efficacy of this regimen in patients with chemosensitive relapsed SCLC.
详细描述
OUTLINE: This is a multi-center study.
Paclitaxel 90 mg/m2 IV infusion over 1 hour days 1, 8 and 15 of 28 day cycle
Plus
Bevacizumab 10 mg/kg on days 1 and 15 of 28 day cycle.
- 1 cycle = 28 days (4 weeks)
- Disease assessments will be performed per RECIST every other cycle
- After a minimum of 4 cycles or a maximum of 6 cycles of combination chemotherapy, bevacizumab monotherapy may continue until disease progression or intolerable side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic proof of small cell lung cancer
- •Chemo-sensitive disease defined as relapsed after 60 days from completion of first line chemotherapy.
- •Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy.
- •Must have received treatment with at least 1 but not more than 2 prior chemotherapy regimens. (At least one regimen must contain a platinum agent. Previous treatment with irinotecan is allowed.)
- •Prior radiation therapy must be completed at least 21 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to ≤ grade 1 or baseline prior to registration.
- •Prior cancer treatment must be completed at least 21 days prior to being registered for protocol therapy and the subject must have recovered from the acute toxicity effects of the regimen prior to registration.
排除标准
- •No treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
- •No history or radiographic evidence of CNS involvement by head CT or MRI within 42 days prior to registration.
- •No history of seizures, transient ischemic attack or stroke.
- •No clinically significant infections as judged by the treating investigator.
- •No other active cancer except SCLC.
- •No prior treatment with topoisomerase I inhibitor.
- •No contraindications to the use of paclitaxel or bevacizumab as per the investigator's clinical judgment.
- •Must not have grade 3 or greater peripheral neuropathy.
- •Must not have had major surgical procedure, open biopsy, or significant traumatic injury within 28 days of being registered for protocol therapy.
- •No anticipation of need for major surgical procedure during the course of the study.
- •Patients may not have had a minor surgical procedure, placement of an access device or fine needle aspiration within 7 days prior to being registered for protocol therapy.
- •No evidence of bleeding diathesis or coagulopathy.
- •No history of deep vein thrombosis or pulmonary embolism.
- •No full dose/therapeutic anticoagulation with either low molecular weight heparin or unfractionated heparin or coumadin within 10 days prior to registration.
- •Patients must not have been using aspirin (>325 mg/day) or another nonsteroidal anti-inflammatory medications known to inhibit platelet function on a daily basis within 10 days prior to registration on study.
- •Patients must not be using any of the following drugs known to inhibit platelet function within 10 days prior to registration: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal).
- •Patients must not have a current non-healing wound or fracture.
- •Patients must not have a history of or current hemoptysis.
研究组 & 干预措施
1
Paclitaxel + Devacizumab in patients with chemosensitive relapsed small cell lung cancer.
干预措施: Paclitaxel (Drug)
1
Paclitaxel + Devacizumab in patients with chemosensitive relapsed small cell lung cancer.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC).
时间窗: 18 months
次要结局
- To determine the response rate of the combination of paclitaxel and bevacizumab with chemosensitive SCLC.(18 months)
- To determine the toxicity of the combination of paclitaxel and bevacizumab in patients with SCLC.(18 months)
- To determine overall survival.(18 months)
- To assess VEGF polymorphisms in the study population.(18 months)