Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Percentage of Participants With Reduction in Grade 3/4 Neutropenia
研究概览
简要总结
The purpose of this study is to find better treatment for lung cancer and to find out what effects the combined treatment of carboplatin and gemcitabine when given with or without dexamethasone have on cancer.
This study will determine if dexamethasone, when given before standard chemotherapy will increase the cancer fighting effects and reduce the side effects of chemotherapy.
详细描述
Subjects enrolled in the study will be placed in one of two treatment arms. All subjects have a 50-50 chance of being placed into either treatment arm. Treatment Arm 1 will receive chemotherapy alone, Treatment Arm 2 will receive chemotherapy with dexamethasone given pre-treatment.
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
- •Untreated, stage IIIB with pleural effusion
- •Untreated, Stage IV, non-small cell lung cancer
- •Recurrent after surgery if no previous radiation therapy or chemotherapy were administered as part of their primary treatment, except for palliative radiotherapy
- •18 years of age or older
- •ECOG PS 0, 1 or 2
- •At Least one target lesion according to the RECIST Criteria
- •Adequate organ and marrow function
排除标准
- •Previous cancer history unless they have had curative treatment completed at least 5 years prior to entry.
- •No previous radiotherapy, chemotherapy or immunotherapy for NSCLC, except for radiation therapy to the brain to control metastasis, bone to control pain, or lung to relieve bronchial obstruction.
- •No radiation therapy for any previous cancer to more than 25% of bone marrow.
- •Uncontrolled, intercurrent illness
- •Non-study corticosteroids
- •Pregnant women
- •Peripheral neuropathy greater than grade 1
- •Uncontrolled seizures, central nervous system disorders
- •Major surgery within 4 weeks of the start of study treatment
- •Lack of complete recovery from major surgery.
- •Lack of physical integrity of upper gastrointestinal tract, inability to swallow tablets
- •Severe acquired or hereditary immunodeficiency
- •Patients with brain metastases must receive definitive treatment (radiation, surgery or both) and be clinically and radiologically stable for 4 weeks & off corticosteroids for at least 2 weeks prior to randomization.
研究组 & 干预措施
1 No Dex
No Dexamethasone
干预措施: Gemcitabine (Drug)
1 No Dex
No Dexamethasone
干预措施: Carboplatin (Drug)
2 Dex
Dexamethasone
干预措施: Gemcitabine (Drug)
2 Dex
Dexamethasone
干预措施: Dexamethasone (Drug)
2 Dex
Dexamethasone
干预措施: Carboplatin (Drug)
结局指标
主要结局
Percentage of Participants With Reduction in Grade 3/4 Neutropenia
时间窗: continuous throughout treatment, up to 25 weeks
Reduction grade 3/4 neutropenia
次要结局
- Effect of Dexamethasone Pre-treatment on Response Rate.(Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment)
- Effect of Dexamethasone Pre-treatment on Overall Survival.(Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days)
- Progression-free Survival(Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days)
研究者
Susanne Arnold
Sponsor/Investigator
University of Kentucky