A Phase 2 Study of Intravenous Administration of REOLYSIN® (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 34
- 主要终点
- Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population
研究概览
简要总结
The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN therapeutic reovirus in combination with paclitaxel and carboplatin is effective and safe in the treatment of squamous cell carinoma of the lung.
详细描述
Lung cancer remains the most common cancer and cause of cancer-related mortality in the United States. In 2008, there was an estimated 215,000 new cases of lung cancer diagnosed and roughly 162,000 deaths from lung cancer (NCI 2009). The majority (85%) of patients with a diagnosis of lung cancer will have non-small cell lung cancer (NSCLC).
The combination of paclitaxel and carboplatin has become the most commonly prescribed chemotherapy regimen for the treatment of advanced NSCLC in the United States. Laboratory studies of combinations of REOLYSIN with a variety of chemotherapeutic agents has shown that the combination of REOLYSIN and paclitaxel was invariably synergistic, even in cells with drug resistance or limited sensitivity to the reovirus. Moreover, reovirus activity was dramatically increased in the presence of the taxane.
The Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given intravenously in combination with paclitaxel and carboplatin every 3 weeks in patients with squamous cell carinoma of the lung.
Response is a primary endpoint of this trial.
The safety of the treatment combination will be assessed by the evaluation of the type, frequency and severity of adverse events, changes in clinical laboratory tests, immunogenicity and physical examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •have histologically or cytologically confirmed metastatic stage IIIB (pleural effusion; IVA on revised IASLC staging) or stage IV, or recurrent squamous cell carcinoma of the lung.
- •have measurable disease.
- •be chemotherapy naïve for their metastatic or recurrent SCCLC, with some exceptions.
- •have NO continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures.
- •have an ECOG Performance Score of ≤
- •have a life expectancy of at least 3 months.
- •absolute neutrophil count (ANC) ≥ 1.5 x 10^9; Platelets ≥ 100 x10^9 (without platelet transfusion);Hemoglobin ≥ 9.0 g/dL (with or without RBC transfusion); Serum creatinine ≤ 1.5 x upper limit of normal (ULN); Bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN.
- •negative pregnancy test for females with childbearing potential.
排除标准
- •receive concurrent therapy with any other investigational anticancer agent while on study.
- •have a known past or current history of brain metastasis(es).
- •be on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
- •be a pregnant or breast-feeding woman.
- •have clinically significant cardiac disease.
- •have dementia or altered mental status that would prohibit informed consent.
- •have any other acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.
结局指标
主要结局
Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population
时间窗: 6 months
次要结局
- Evaluate the safety and tolerability of the treatment regimen in the study population as measured by adverse events associated with the study treatment, and defined by established criteria.(Within 30 days of last dose of REOLYSIN)
- To assess progression-free survival (PFS) for the treatment regimen in the study population.(9-12 months)
- Determine the proportion of patients receiving the treatment who are alive and free of disease progression at 6 months.(6 months)
- To determine overall survival with the treatment regimen in the study population(9-12 months)