A Phase II Trial Using Intravenous Iron in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia Treated With 120,000 Units Epoetin Alfa Every Three Weeks
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Achieve hemoglobin responses > 2g/dl in at least 70% of patients
研究概览
简要总结
The purpose of this study is to find a better, more convenient way to improve anemia results by increasing the amount of medication given at 3 week intervals. Researchers want to know if giving a higher dose of Procrit® and intravenous (IV) iron once every 3 weeks would give better results in treating anemia without the need for more office visits.
详细描述
There are more than 170,000 patients diagnosed with lung cancer in the United States each year and many will develop anemia (iron deficiency) during the course of treatment. Anemia is associated with poor quality of life and treatment delays for advanced lung cancer. The treatment of iron deficiency anemia is with iron. Iron is an essential mineral used in red blood cells to carry oxygen throughout the body. Iron is necessary to make hemoglobin, a key element in red blood cells.
The FDA has approved Procrit® (epoetin alfa) to treat anemia in people with non-myeloid (bone marrow) malignancies. Procrit® is a man-made, injectable drug for treating anemia and it encourages red cell production. While the administration of intravenous iron therapy, injected into veins through an IV, did increase the response rate of Procrit® in a previous study, researchers want to find out the best amount of drug to use and the best time to administer Procrit®, along with ferric gluconate, (Ferrlecit®), added for lack of iron.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically confirmed small cell or non small cell lung cancer
- •Stage III or Stage IV lung cancer
- •Platinum containing chemotherapy induced anemia (< 10 g/dl Hb)
- •Cancer related anemia (<10 g/dl Hb) at time of initiation of chemotherapy
- •ECOG performance status of 0,1, or 2
- •Informed consent
- •Expected to receive platinum based outpatient chemotherapy for at least nine weeks
排除标准
- •Pregnant women
- •Intolerance to epoetin alfa or parenteral iron
- •More than 2 cycles of the planned platinum chemotherapy at time of enrollment
- •Chronic GI bleed (> than 4 weeks positive hemoccult or gastroccult)
- •Ferritin > 500 mg/dl
- •Anemia due to other causes than cancer or chemotherapy
- •Previous parenteral iron therapy
- •Uncontrolled hypertension (systolic BP > 160, diastolic > 100 mmHg)
研究组 & 干预措施
Epoetin Alfa plus Iron
干预措施: Epoetin Alfa plus Iron (Drug)
结局指标
主要结局
Achieve hemoglobin responses > 2g/dl in at least 70% of patients
时间窗: Nine weeks, after at least two doses of 120,000 units epoetin alfa
次要结局
- Descriptive evaluation of adverse effects of parenteral iron and epoetin alfa 120,000 units given every three weeks(Patient follow up until week 12)
研究者
Goetz Kloecker
Associate Professor
University of Louisville