NCT01076504已完成2 期
A Phase II Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 20
- 主要终点
- 1-year Survival
研究概览
简要总结
This proposed trial will investigate the combination of amrubicin and carboplatin in the first-line treatment of patients with extensive-stage small cell lung cancer (ES- SCLC). Since myelosuppression is the most common toxicity produced by this drug combination, pegfilgrastim will be administered with each treatment cycle. This trial will be the first clinical trial to evaluate a combination of amrubicin and carboplatin in the first-line treatment of ES SCLC in a U.S. population.
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
- •Cytologically and/or histologically confirmed small-cell lung cancer with extensive stage disease.
- •Measurable or evaluable disease per RECIST criteria version 1.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-
- •Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).
- •QTc interval of ≤450 msec. on ECG.
- •Adequate organ function, including the following:
- •ANC ≥1500 cells/micro liter
- •Platelet count ≥100,000 cells/micro liter
- •Hemoglobin ≥9 g/dL
- •Total bilirubin ≤1.5 x ULN; AST/ALT ≤2.5 x ULN, (except if due to hepatic metastases, then ≤5 x ULN)
- •Serum creatinine ≤1.5 x ULN
- •Patients must be able to receive growth factors (G-CSF).
- •Women of childbearing potential must have a negative serum or urine pregnancy test performed ≤ 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
- •Patients ≥18 years of age.
- •Patients must be accessible for treatment and follow-up.
- •Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
排除标准
- •Previous treatment for limited-stage SCLC.
- •Previous chemotherapy or radiation therapy for SCLC (unless radiation was administered for brain metastases).
- •Active brain metastases. Patients with treated brain metastases are eligible, if (1) radiation therapy was completed ≥ 21 days prior to first dose of amrubicin; (2) follow-up scan shows no disease progression; an absence of neurologic symptoms and (3) patient does not require steroids.
- •Mixed small cell/non-small cell tumors or other neuroendocrine lung cancers.
- •Women who are pregnant or breastfeeding.
- •Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.
- •Patients with New York Heart Association (NYHA) class II or greater congestive heart failure (CHF).
- •Any of the following ≤6 months prior to starting study treatment:
- •myocardial infarction;
- •severe unstable angina;
- •ongoing cardiac dysrhythmia.
- •Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia.
- •Treatment for other invasive cancers during the previous 5 years, or the presence of any active invasive cancer of any type (with the exception of non-melanoma skin cancers).
- •Uncontrolled hypertension (i.e., blood pressure >150/90 mmHg that cannot be controlled with standard anti-hypertensive agents).
- •Major surgical procedure or significant traumatic injury ≤ 28 days of study initiation.
- •History of seropositive HIV or patients who are receiving immunosuppressive medications that would in the opinion of the investigator increase the risk of the serious neutropenic complications.
- •Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Any condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- •Use of any non-approved or investigational agent ≤30 days prior to administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
研究组 & 干预措施
Amrubicin/Carboplatin with Pegfilgrastim
Experimental
Systemic therapy
干预措施: Amrubicin (Drug)
Amrubicin/Carboplatin with Pegfilgrastim
Experimental
Systemic therapy
干预措施: Carboplatin (Drug)
Amrubicin/Carboplatin with Pegfilgrastim
Experimental
Systemic therapy
干预措施: Pegfilgrastim (Drug)
结局指标
主要结局
1-year Survival
时间窗: 12 months
Percentage of patients still alive one year after their first treatment
次要结局
- Objective Response Rate(36 months)
- Time to Progression(36 months)
- Overall Survival(84 months)
- Toxicity/Safety(36 months)
研究者
研究点 (20)
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