N/A
Completed N=434
An Observational Study of the Ethnic Impact of Patients Undergoing Second (2nd) Line Treatment for Non-Small Cell Lung Cancer Using Pemetrexed
Source: ClinicalTrials.gov NCT00497770 ↗Enrolled (actual)
434
Serious AEs
6.2%
Results posted
Apr 2012
Primary outcomePrimary: Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate) — 43.7; 45.0; 53.33; 34.6 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate) |
43.7; 45.0; 53.33; 34.6 | — |
| SECONDARY Overall Survival |
6.77; 6.90; 16.0; 5.35 | — |
| SECONDARY Progression Free Survival |
2.66; 2.99; 5.08; 2.20 | — |
| SECONDARY Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals |
63.2; 63.1; 70.3; 71.4; 24.3; 23.1 | — |
| SECONDARY 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 |
62.2; 63.1; 62.2; 50.0; 29.6; 32.3 | — |
| SECONDARY Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances |
78.6; 67.7; 83.8; 71.4; 11.5; 26.2 | — |
| SECONDARY Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities |
44.1; 44.6; 54.1; 42.9; 38.2; 33.8 | — |
| SECONDARY Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications |
79.3; 73.8; 86.5; 85.7; 12.8; 21.5 | — |
| SECONDARY 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 |
57.2; 58.5; 59.5; 50.0; 29.9; 32.3 | — |
| SECONDARY Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone |
86.5; 90.8; 86.5; 92.9; 5.6; 4.6 | — |
| SECONDARY Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC) |
3.37; 3.73; 3.89; 3.75; 3.52; 5.16 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00497770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.