NCT00043862已完成2 期
A Phase II Trial of Twice Daily Oral Topotecan as a Radiation Sensitizer With Twice Daily Radiotherapy for Newly Diagnosed 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
- 60
- 试验地点
- 32
- 主要终点
- Response rate
研究概览
简要总结
This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy.
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
- •Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with no prior radiotherapy. Patients are allowed to have had a resection or biopsy.
- •Women of reproductive potential must have a negative serum pregnancy test at the study screening visit.
- •Patients must give written informed consent to participate in the study.
- •Patients must be able to take oral medication.
- •Patients should be completely recovered from recent surgery.
- •Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.
- •Patients must be evaluated by the radiation oncologist prior to study entry.
排除标准
- •Extensive Stage SCLC.
- •Women who are pregnant or lactating.
- •Use of an investigational drug within 30 days prior to the first dose of study medication.
- •Any medically/clinically significant active infection.
- •Symptoms of the SCLC spreading to the brain.
- •Patients with limited stage SCLC who have undergone complete resection with no measurable disease prior to starting chemotherapy.
- •Severe medical problems, unrelated to SCLC, that would limit the patient's full ability to follow all study rules and procedures, or that would expose the patient to extreme risk.
- •Other ongoing, immunotherapy or radiotherapy being administered at the time as study participation.
结局指标
主要结局
Response rate
次要结局
- Time to Progression, response duration, survival, quantitative and qualitative assessment of tolerability
研究者
研究点 (32)
Loading locations...
相似试验
已完成
2 期
S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung CancerExtensive Stage Small Cell Lung CancerRecurrent Small Cell Lung CancerNCT00828139National Cancer Institute (NCI)189
已完成
2 期
Weekly Topotecan in Patients Treated for Metastatic Colorectal CancerColon CancerNCT00193167SCRI Development Innovations, LLC40
已完成
3 期
Efficacy and Safety of 2 Doses of Tiotropium Via Respimat Compared to Placebo in Adolescents With Moderate Persistent AsthmaAsthmaNCT01257230Boehringer Ingelheim398
已完成
2 期
Efficacy Study of Weekly Taxotere and Topotecan for Recurrent Gynecologic (GYN) CancersOvarian NeoplasmsUterine NeoplasmsNCT00231855Montefiore Medical Center31
已完成
2 期
Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in AdolescentsGastroesophageal Reflux DiseaseErosive EsophagitisNCT01642615Takeda63