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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00497770
First received: July 5, 2007
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Lung Neoplasms
Drug: Pemetrexed

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-small Cell Lung Cancer: The Impact of Ethnic Origin on Patients Being Treated Second Line With Pemetrexed - An Observational Study

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate) [ Time Frame: baseline to measured progressive disease (up to 20 cycles [14 months]) ] [ Designated as safety issue: No ]
    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:
  • Overall Survival [ Time Frame: baseline to date of death from any cause (up to 20 cycles [14 months]) ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to measured progressive disease or death (up to 20 cycles [14 months]) ] [ Designated as safety issue: No ]
    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 Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals [ Time Frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) ] [ Designated as safety issue: No ]
    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 [ Time Frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) ] [ Designated as safety issue: No ]
    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 [ Time Frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) ] [ Designated as safety issue: No ]
    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 [ Time Frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) ] [ Designated as safety issue: No ]
    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.

  • Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications [ Time Frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) ] [ Designated as safety issue: No ]
    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 [ Time Frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) ] [ Designated as safety issue: No ]
    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 [ Time Frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months]) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and end of treatment (up to 20 cycles [14 months]) ] [ Designated as safety issue: No ]
    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.


Enrollment: 434
Study Start Date: February 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Caucasian
Caucasian patients receiving Alimta for 2nd line NSCLC
Drug: Pemetrexed
Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient
Other Names:
  • LY231514
  • Alimta
African American
African American patients receiving Alimta for 2nd line NSCLC
Drug: Pemetrexed
Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient
Other Names:
  • LY231514
  • Alimta
Asian American
Asian American patients receiving Alimta for 2nd line NSCLC
Drug: Pemetrexed
Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient
Other Names:
  • LY231514
  • Alimta
Hispanic
Hispanic patients receiving Alimta for 2nd line NSCLC
Drug: Pemetrexed
Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient
Other Names:
  • LY231514
  • Alimta

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients receiving pemetrexed for second (2nd) line treatment of non-small cell lung cancer (NSCLC): 400 Caucasians, 200 African-Americans, 200 Asian-Americans, and 200 Hispanic patients will be accrued to this study.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497770

  Show 38 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00497770     History of Changes
Other Study ID Numbers: 10733, H3E-US-B001
Study First Received: July 5, 2007
Results First Received: March 15, 2012
Last Updated: April 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014