An Observational Study of the Ethnic Impact of Patients Undergoing Second (2nd) Line Treatment for Non-Small Cell Lung Cancer Using Pemetrexed

Eli Lilly and Company434 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

434

Conditions

Lung Neoplasms

Interventions

PemetrexedDRUG

Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Pregnant or lactating females

Locations (38)

Outcomes

Primary Outcomes

Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)

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.

Time frame: baseline to measured progressive disease (up to 20 cycles [14 months])

Secondary Outcomes

Overall Survival

Overall survival is the duration (months) from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Time frame: baseline to date of death from any cause (up to 20 cycles [14 months])

Progression Free Survival

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.

Time frame: baseline to measured progressive disease or death (up to 20 cycles [14 months])

Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals

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.

Time frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])

Data from ClinicalTrials.gov

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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.

Mobile, Alabama, United States

Glendale, Arizona, United States

Anaheim, California, United States

Campbell, California, United States

Daly City, California, United States

La Jolla, California, United States

Lancaster, California, United States

Mission Hills, California, United States

Palo Alto, California, United States

Poway, California, United States

...and 28 more locations

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

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.

Time frame: 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

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.

Time frame: 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

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.

Time frame: 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 Prepare and Take Medications

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.

Time frame: 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

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.

Time frame: 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

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.

Time frame: 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)

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.

Time frame: Baseline and end of treatment (up to 20 cycles [14 months])