Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 22
- 主要终点
- To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel
研究概览
简要总结
The purpose of this study is to determine if the addition of motexafin gadolinium (study drug) to standard treatment with docetaxel will improve the response rate in patients with non-small cell lung cancer.
详细描述
Preclinical and clinical data suggest that MGd has activity in NSCLC and that the combination of MGd and docetaxel may be more effective that docetaxel alone. In this trial, patients will receive 10 mg/kg MGd followed by 75 mg/m2 once every 3 weeks. This dosing regimen was well tolerated in the Phase I dose escalation trial. A Simon 2-stage trial design will be used; if at least 4 out of 39 evaluable patients in the first stage of the trial demonstrate objective clinical response, the study will proceed to Stage 2, where an additional 22 evaluable patients will be enrolled following the same treatment regimen and assessment schedule as in Stage 1. Patients with stable disease, CR, or PR will continue dosing up to 12 cycles and will be followed for response every 6 weeks until PD, death, or end of study.
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
- •≥ 18 years old
- •Histologically or cytologically confirmed diagnosis of NSCLC
- •Inoperable Stage IIIA, unresectable Stage IIIB or metastatic NSCLC patients who have received 1 prior platinum-based chemotherapy regimen
- •Measurable disease per RECIST
- •ECOG performance status score of 0 or 1
- •Willing and able to provide written informed consent
排除标准
- •Laboratory values of: ANC < 1500/mm³, Platelet count < 100,000/mm³, hemoglobin < 10 g/dL, AST or ALT > 2.5 x upper limit of normal (ULN), Alkaline phosphatase > 5 x ULN, bilirubin > 1.5 x ULN, serum creatinine > 2.0 mg/dL (176 umol/dL), albumin < 3.0 g/dL (30 g/L)
- •Symptomatic or uncontrolled (untreated or treated and progressing) brain metastases
- •Evidence of meningeal metastasis
- •> 1 prior cytotoxic regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen, or prior MGd)
- •Chemotherapy, radiation therapy, experimental therapy, immunotherapy, or systemic biologic anticancer therapy within 21 days before beginning study treatment
- •Significant weight loss ≥ 10% of body weight within preceding 6 weeks
- •Treatment for another cancer within 3 years before enrollment, except basal cell carcinoma of the skin or cervical cancer in situ
- •Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association Class III or IV
- •Uncontrolled hypertension (systolic blood pressure > 160 mm Hg and diastolic blood pressure > 110 mm Hg on maximal medical therapy)
- •Known history of porphyria (testing not required at screening visit)
- •Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening visit)
- •History of hypersensitivity to taxanes or polysorbate 80
- •Known history of HIV infection (testing not required at screening visit)
- •Female who is pregnant or lactating (serum pregnancy test is required for all female patients of childbearing potential)
- •Sexually active male or female of childbearing potential unwilling to use adequate contraceptive protection
- •Physical or mental condition that makes patient unable to complete specified follow-up assessments
研究组 & 干预措施
Xcytrin® (motexafin gadolinium)
干预措施: Motexafin Gadolinium (Drug)
结局指标
主要结局
To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel
时间窗: up to 12 cycles
The patient population for the primary endpoint is all patients who underwent at least 1 cycle of treatment and at 1 response evaluation.
次要结局
- To estimate the time of progression(up to 12 cycles)
- To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC(Up to 12 cycles)
- To estimate overall survival(up to 12 cycles)
- To estimate progression-free survival(up to 12 cycles)
- To estimate duration of response (CR + PR)(Up to 12 cycles)
- To estimate clinical benefit rate (CR + PR + stable disease [SD])(up to 12 cycles)