Performance Status During Treatment With Pemetrexed in Patients With NSCLC

Non Small Cell Lung Cancer Clinical Trial

— PERFORMANCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540241
• Other study ID #: 11826
• Secondary ID: H3E-SB-B007
• Status: Completed
• Phase: N/A
• First received: October 4, 2007
• Last updated: March 28, 2011
• Start date: September 2007
• Est. completion date: March 2010

Study information

• Verified date: March 2011
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 542
• Est. completion date: March 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• Pemetrexed
in-label use

Locations

Country	Name	City	State
Germany	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.	Bad Homburg

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

External Links

•   (Lilly Clinical Trial Registry)