Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 26
- 主要终点
- Progression-free survival
研究概览
简要总结
PI-88 is a new experimental drug that inhibits tumour growth by reducing the formation of new blood vessels into tumours. Docetaxel is a standard second-line treatment offered to patients with non-small-cell lung cancer who haven't responded to first-line therapies (platinum-based drugs or radiotherapy). Of this group of patients, only 20% remain progression-free 6 months after starting docetaxel treatment. The PR88202 study has been designed to compare two different cancer treatments (docetaxel only, and docetaxel plus PI-88) and to work out which is more effective against the cancer. It is hoped that the combination of PI-88 with docetaxel will allow patients to extend the time it takes for their disease to progress, and also to improve their quality of life.
详细描述
PR88202 is an open-label randomized study. In the initial phase of the study, patients will be randomized to receive weekly docetaxel alone, or PI-88 in combination with weekly docetaxel. Both groups will receive docetaxel (30 mg/m2), administered by intravenous infusion on days 1, 8 and 15 of a 28-day cycle. The second group only will receive PI-88 (250 mg/day) in addition to docetaxel; PI-88 will be administered by subcutaneous injection on days 1-4, 8-11 and 15-18 of each cycle. The primary efficacy endpoint is the non-progression rate at 6 months. In the extension phase of the study, patients in the combination arm who have stable disease or an objective response after up to six treatment cycles will remain on PI-88 alone as maintenance therapy. Patients who initially receive docetaxel alone and who have disease progression or unacceptable toxicity before the completion of six cycles will be eligible to receive PI-88 alone as third-line therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •histologically or cytologically confirmed stage IIIb or IV NSCLC that has progressed during or after first-line treatment
- •measurable disease by spiral CT chest scan, as defined in RECIST criteria
- •performance status 0-1 (ECOG)
- •life expectancy at least 2 months
- •adequate hemopoietic, renal and hepatic function
排除标准
- •current symptomatic central nervous system (CNS) involvement
- •prior or co-existent malignancies
- •significant non-malignant disease
- •acute or chronic gastrointestinal (GI) bleeding in last two years
- •inflammatory bowel disease
- •abnormal bleeding tendency
- •patients at risk of bleeding due to open wounds or planned surgery
- •clinically significant hemoptysis within the past 4 weeks
- •bilirubin > upper limit of normal (ULN)
- •ALT and AST > 2.5 times ULN, or > 1.5 times ULN if alkaline phosphatase > 2.5 times ULN
- •alkaline phosphatase > 5 times ULN, unless patient has bone metastases
- •myocardial infarction, stroke or congestive heart failure within last 3 months
- •prior treatment with docetaxel
- •concomitant treatment with aspirin (>100 mg/day), NSAIDs (except selective COX-2 inhibitors, warfarin (>1 mg/day), heparin, LMWH, anti-platelet drugs, CYP3A4 inhibitors
- •women who are pregnant or breast-feeding
- •women of child-bearing potential not using adequate contraception
- •history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin
- •history of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease
- •allergy to polysorbate 80 (component of Taxotere®)
- •uncontrolled or serious infection in last 4 weeks
结局指标
主要结局
Progression-free survival
次要结局
- Time to progression
- Response rate
- Quality of life
- Overall survival