Non-small Cell Lung Cancer: The Impact of Ethnic Origin on Patients Being Treated Second Line With Pemetrexed - An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)
研究概览
简要总结
This large, non-randomized observational study is being conducted to provide data about the impact of ethnic origin on outcomes and resource utilization during the 2nd line treatment of non-small cell lung cancer (NSCLC) in a routine medical care setting.
详细描述
This is a large 1000 patient single arm observational study being conducted to determine the impact of ethnic origin (Caucasian, African-Americans, Asian-Americans, and Hispanics) on patients being treated for 2nd line advanced NSCLC with pemetrexed given in routine clinical practice. Data will be collected on disease control rate by pemetrexed as defined by Response Rate (RR) (Complete Response (CR) + Partial Response (PR)), Stable Disease (SD) and toxicities. In addition, overall survival, progression-free survival, treatment toxicities, activities of daily living, symptom burden and resource utilization will also be observed. To meet the study goals, a total of 400 Caucasians, 200 African- Americans, 200 Asian-Americans, and 200 Hispanics will be accrued to this study.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Non-small cell lung cancer (NSCLC) (any histologic type)
- •Stage IIIB or IV disease
- •Should have had 1 line of chemotherapy for Metastatic disease
- •Adequate hematologic, hepatic and renal function
- •Measurable or evaluable disease
排除标准
- •Pregnant or lactating females
研究组 & 干预措施
Caucasian
Caucasian patients receiving Alimta for 2nd line NSCLC
干预措施: Pemetrexed (Drug)
African American
African American patients receiving Alimta for 2nd line NSCLC
干预措施: Pemetrexed (Drug)
Asian American
Asian American patients receiving Alimta for 2nd line NSCLC
干预措施: Pemetrexed (Drug)
Hispanic
Hispanic patients receiving Alimta for 2nd line NSCLC
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)
时间窗: baseline to measured progressive disease (up to 20 cycles [14 months])
Disease Control Rate \[DCR\] is the percentage of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), and SD or Incomplete Response (SI). Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; SD=small changes not meeting above criteria; SI=persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.
次要结局
- Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals(beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]))
- Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation(beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]))
- Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances(beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]))
- Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities(beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]))
- Overall Survival(baseline to date of death from any cause (up to 20 cycles [14 months]))
- Progression Free Survival(baseline to measured progressive disease or death (up to 20 cycles [14 months]))
- Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications(beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]))
- Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping(beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]))
- Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone(beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]))
- Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)(Baseline and end of treatment (up to 20 cycles [14 months]))