An Observational Study of the Ethnic Impact of Patients Undergoing Second (2nd) Line Treatment for Non-Small Cell Lung Cancer Using Pemetrexed
- Registration Number
- NCT00497770
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 434
- 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
- Pregnant or lactating females
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Caucasian Pemetrexed Caucasian patients receiving Alimta for 2nd line NSCLC African American Pemetrexed African American patients receiving Alimta for 2nd line NSCLC Asian American Pemetrexed Asian American patients receiving Alimta for 2nd line NSCLC Hispanic Pemetrexed Hispanic patients receiving Alimta for 2nd line NSCLC
- Primary Outcome Measures
Name Time Method Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate) 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.
- Secondary Outcome Measures
Name Time Method 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]) The daily activities assessed: ability to plan and prepare meals. OARS-IADL assesses the participant's ability to plan and prepare meals at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
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]) The daily activities assessed: ability to drive or use public transportation. OARS-IADL assesses the participant's ability to drive or use public transportation at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
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]) The daily activities assessed: ability to handle personal finances. OARS-IADL assesses the participant's ability to handle personal finances at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
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]) The daily activities assessed: ability to perform housework activities. OARS-IADL assesses the participant's ability to perform housework activities at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Overall Survival baseline to date of death from any cause (up to 20 cycles [14 months]) Overall survival is the duration (months) from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Progression Free Survival baseline to measured progressive disease or death (up to 20 cycles [14 months]) Time from start of second line therapy until death, disease progression, or last contact expressed in months. Participants lost to follow-up (that were alive at last contact) were treated as censored using Kaplan-Meier survival analysis method.
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]) The daily activities assessed: ability to prepare and take medications. OARS-IADL assesses the participant's ability to prepare and take medications at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
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]) The daily activities assessed: ability to do the act of shopping. OARS-IADL assesses the participant's ability to do the act of shopping at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
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]) The daily activities assessed: ability to operate the telephone. OARS-IADL assesses the participant's ability to operate the telephone at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
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]) The symptom score assessed: pain, fatigue, nausea, sleep, distress, shortness of breath, memory, appetite, drowsy, dry mouth, sadness, vomiting, numbness, cough, constipation, general activity, mood, work, relationships with other people, walking, enjoyment. Scores for each item range from 0 to 10, where 0 equaled no symptoms and 10 equaled worst possible symptoms. Assessed at baseline and end of treatment.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇵🇷San Juan, Puerto Rico