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Performance Status During Treatment With Pemetrexed in Patients With NSCLC

Performance Status and Influencing Factors During Second-Line Treatment With Pemetrexed in Patients With Stage III/IVNon Small Cell Lung Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00540241
Acronym
PERFORMANCE
Enrollment
542
Registered
2007-10-05
Start date
2007-09-30
Completion date
2010-03-31
Last updated
2011-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Brief summary

The primary research objective of this observational study in pretreated patients with NSCLC of Stage IIIa/b or Stage IV is to evaluate patients' Karnofsky Index (KI) after the second cycle of second-line treatment with single agent pemetrexed in a real life setting, and to evaluate factors potentially influencing performance status in terms of KI, i.e. frequency of use of concomitant medications, in particular analgesics, folic acid, Vitamin B12, antiemetics, and medications against diarrhea; as documented in patient diary (days of use per week) and by the physicians.

Interventions

DRUGPemetrexed

in-label use

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Are 18 years of age or older * Have NSCLC, Stage IIIa/b or IV, that is not amenable to curative therapy * Have had one prior chemotherapy regimen with cytotoxic agents for the treatment of NSCLC (patients with adjuvant and neoadjuvant regimens are also eligible. However, patients with one prior cytotoxic chemotherapy followed by a targeted agent such as erlotinib are not eligible because the targeted agent would be regarded as second-line treatment) * Are initiating second-line of treatment for NSCLC with pemetrexed * Have been fully informed and have given written consent for the use of their data.

Exclusion criteria

* Have received any prior treatment with pemetrexed * Are participating in a study including administration of any investigational drug or procedure at entry into this study

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026