NCT00417248终止1 期
A Phase II Trial of Concurrent Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN06-107
Nasser Hanna, M.D.8 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 8
- 主要终点
- Time to Disease Progression (TTP)
研究概览
简要总结
Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.
详细描述
Outline: This is a multi-center study.
Chemotherapy/radiation therapy (2 cycles)
- Cisplatin 50 mg/m2 IV days 1 and 8 of 28 day cycle
- Etoposide 50 mg/m2 IV days 1-5 of 28 day cycle
- Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) with the following:
Maintenance therapy of Sorafenib 400 mg PO BID of 28 day cycle, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 1 year.
Patients with progressive disease will discontinue treatment.
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
- •Histological or cytological proof of non-small cell lung cancer (NSCLC).
- •Measurable or non-measurable disease per RECIST.
- •Unresectable Stage IIIA or IIIB disease as evaluated by imaging.
- •Must be age ≥ 18 years at the time of consent.
- •Written informed consent and HIPAA authorization for release of personal health information.
- •Females of childbearing potential and males must be willing to use an effective method of contraception.
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for initial therapy.
排除标准
- •No prior chemotherapy or radiotherapy for lung cancer.
- •No positive supraclavicular or scalene lymph nodes extending up into the cervical region.
- •No superior sulcus (pancoast tumors).
- •No malignant pleural effusions. The only exception is a patient with a pleural effusion visible only on CT scan (and not visible on CXR) OR deemed too small to tap.
- •No clinically significant or malignant pericardial effusions.
- •No CNS metastases.
- •No unintended weight loss (> 5% body weight) in the preceding 90 days prior to registration for initial therapy.
- •No treatment with any investigational agent within 30 days prior to being registered for initial therapy.
- •No prior therapy with a Ras pathway inhibitor or anti-angiogenic agent.
- •No other active cancers.
- •Females must not be breastfeeding.
- •No active clinically serious infections as judged by the treating investigator (> CTC v3, Grade 2) including known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- •No major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for initial therapy.
- •No anticipation of need for major surgical procedure during the course of the study.
- •No minor surgical procedures such as fine needle aspirations or cone biopsies within 7 days prior to registration for initial therapy.
- •No history of allergic reactions to drugs utilizing the vehicle polysorbate 80 + polyethylene glycol (etoposide).
- •No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for initial therapy.
- •No use inhibitors or inducers of the cytochrome p450 system CYP3A4 enzyme or other medications such as aprepitant, ketoconazole, itraconazole, quinidine, digoxin, cyclosporine, ritonavir, grapefruit products, St. John's Wort, rifampin (rifampicin), carbamazepine, phenytoin, dexamethasone, and phenobarbital.
- •No evidence or history of bleeding diathesis or coagulopathy.
- •No serious non-healing wound, ulcer, or bone fracture.
- •No known or suspected allergy to sorafenib.
- •No uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management.
- •No thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within 6 months prior to registration for initial therapy.
- •No pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks prior to registration for initial therapy.
- •No hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to registration for initial therapy.
- •No condition that impairs patient's ability to swallow whole pills or any malabsorption problem.
研究组 & 干预措施
Investigational Treatment
Experimental
Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
干预措施: Cisplatin (Drug)
Investigational Treatment
Experimental
Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
干预措施: Etoposide (Drug)
Investigational Treatment
Experimental
Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
干预措施: Radiotherapy (Procedure)
Investigational Treatment
Experimental
Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
干预措施: Sorafenib (Drug)
结局指标
主要结局
Time to Disease Progression (TTP)
时间窗: 18 months
次要结局
- Overall Survival(18 months)
研究者
Nasser Hanna, M.D.
Sponsor-Investigator
Hoosier Cancer Research Network
研究点 (8)
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