NCT00531934已完成2 期
A Randomized, Open Label Study to Evaluate the Effect of Doxycycline on Tarceva-induced Skin Rash in Patients With Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
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
- 147
- 主要终点
- Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment
研究概览
简要总结
This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-75 years of age;
- •confirmed non-small cell lung cancer;
- •failure after first line chemotherapy for advanced disease, and scheduled for second line therapy with Tarceva.
排除标准
- •rash of any etiology at study entry;
- •history of significant heart disease;
- •any other malignancies (other than adequately treated squamous cell skin cancer, or in situ cancer of the cervix);
- •history of allergic reactions to tetracyclines.
研究组 & 干预措施
1
Experimental
干预措施: Doxycline (Drug)
1
Experimental
干预措施: erlotinib [Tarceva] (Drug)
2
Active Comparator
干预措施: erlotinib [Tarceva] (Drug)
结局指标
主要结局
Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment
时间窗: Days 0, 14, 28 and Months 2, 3, and 4
Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation.
次要结局
- Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment(Days 0, 14, 28 and Months 2, 3, and 4)
- Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type(Days 0, 14, 28 and Months 2, 3, and 4)
- Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity(Days 0, 14, 28 and Months 2, 3, and 4)
- Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment(Months 7, 10, and 12)
- Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment(Months 7, 10, and 12)
- Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type(Months 7, 10, and 12)
- Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity(Months 7, 10, and 12)
- Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event(Days 0, 14, 28 and Months 2, 3, and 4)
- Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event(Days 0, 14, 28 and Months 2, 3, and 4)
- Percentage of Participants Estimated to be Event Free at 4 Months(Days 0, 14, 28 and Months 2, 3, and 4)
- Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event(Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12)
- Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event(Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12)
- Percentage of Participants Estimated to be Event Free at 12 Months(Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12)
- Duration of Skin Rash (Folliculitis) During the Whole Treatment Period(Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12)
- Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment(Days 0, 14, 28 and Months 2, 3, and 4)
- Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type(Days 0, 14, 28 and Months 2, 3, and 4)
- Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity(Days 0, 14, 28 and Months 2, 3, and 4)
- Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction(Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12)
- Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment(Days 0, 14, 28 and Months 2, 3, and 4)
- Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction(Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12)
- Percentage of Participants With Global Disease Control by Visit(Months 2, 4, 7, 10, and 12)
- Dermatology Life Quality Index (DLQI) Global Score(Baseline, Days 14 and 28 and Months 2, 3, and 4)
- Percentage of Participants by Best Global Response Under Treatment(Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12)
- Progression-Free Survival (PFS) - Percentage of Participants With an Event(Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12)
- Progression-Free Survival (PFS) - Time to Event(Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12)
- Percentage of Participants Estimated to be Progression Free at 4 and 12 Months(Months 4 and 12)
- Overall Survival (OS) - Percentage of Participants With an Event(Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12)
- Overall Survival (OS) - Time to Event(Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12)
- Percentage of Participants Estimated to be Alive at 4 and 12 Months(Months 4 and 12)
- Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life(Baseline, Days 14 and 28 and Months 2, 3, and 4)
- Quality of Life Score as Assessed by Visual Analog Scale (VAS)(Baseline, Days 14 and 28, and Months 2, 3, and 4)
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