Performance Status During Treatment With Pemetrexed in Patients With NSCLC

NCT00540241 | Completed

• 2 other identifiers: 11826H3E-SB-B007
• Study Type: observational
• Target: 542
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Study Arms (1)

Second-line pemetrexed treatment in NSCLC

Patients with NSCLC who will start second-line treatment with pemetrexed.

Drug: Pemetrexed

Interventions

Pemetrexed DRUG

in-label use

Also known as: Alimta

Second-line pemetrexed treatment in NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with NSCLC Stage IIIa/b or IV who have previously been treated with chemotherapy and are starting second-line treatment with single-agent pemetrexed are eligible for this observational study. Patients must have received one prior chemotherapy regimen. Patients who received prior neoadjuvant or adjuvant therapy are also eligible. Both, in- and outpatients are eligible.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 61352, Germany

Location

Related Publications (1)

• Schuette W, Tesch H, Buttner H, Krause T, Soldatenkova V, Stoffregen C. Second-line treatment of stage III/IV non-small-cell lung cancer (NSCLC) with pemetrexed in routine clinical practice: evaluation of performance status and health-related quality of life. BMC Cancer. 2012 Jan 13;12:14. doi: 10.1186/1471-2407-12-14.

  PMID: 22244076 DERIVED

Related Links

• (Lilly Clinical Trial Registry)

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 5, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: March 1, 2010
• Last Updated: March 29, 2011

Record last verified: 2011-03

Locations

DE (1)