NCT00129844已完成2 期
Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 16
- 主要终点
- To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC
研究概览
简要总结
The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.
详细描述
Outline:
Two-arm, open-label, randomized, 2-stage Phase II trial. Patients will be randomized on the first stage to 1 of 2 treatment arms:
Arm A - 10 mg/kg MGd once per week
Arm B - 15 mg/kg MGd once every 3 weeks
Patients will be treated on 3 week cycles, up to a maximum of 8 cycles (24 weeks). Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy. Patients with progressive disease will be terminated from the study.
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
- •>18 years old
- •Histologically or cytologically confirmed diagnosis of NSCLC
- •Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC patients who have received one prior platinum-based chemotherapy regimen
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •ECOG performance status score of 0 or 1
- •Willing and able to provide written informed consent
排除标准
- •Laboratory values of:
- •Absolute neutrophil count < 1500/ul;
- •Platelet count < 75,000/ul;
- •Hemoglobin < 10 gm/dl;
- •AST or ALT > 3 x the upper limit of normal (ULN);
- •Alkaline phosphatase > 5 x ULN;
- •Bilirubin > 2 x ULN;
- •Serum creatinine > 2.0 mg/dL.
- •Symptomatic or uncontrolled (untreated or treated and progressing) brain metastasis.
- •Evidence of meningeal metastasis.
- •Greater than one prior cytotoxic regimen (not counting adjuvant or neoadjuvant cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen).
- •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 in preceding 6 weeks.
- •Treatment for another cancer within 3 years of enrollment, unless basal cell carcinoma or cervical cancer in situ.
- •Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association (NYHA) 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).
- •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.
结局指标
主要结局
To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC
次要结局
- To select the most effective regimen based on tumor response
- To estimate the time to progression
- To estimate survival
- To evaluate the safety and tolerability of 2 dosing regimens of MGd in NSCLC patients
研究者
研究点 (16)
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