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Performance Status During Treatment With Pemetrexed in Patients With NSCLC (PERFORMANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00540241
Recruitment Status : Completed
First Posted : October 5, 2007
Last Update Posted : March 29, 2011
Information provided by:
Eli Lilly and Company

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.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Drug: Pemetrexed

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Study Type : Observational
Actual Enrollment : 542 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Performance Status and Influencing Factors During Second-Line Treatment With Pemetrexed in Patients With Stage III/IVNon Small Cell Lung Cancer
Study Start Date : September 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Second-line pemetrexed treatment in NSCLC
Patients with NSCLC who will start second-line treatment with pemetrexed.
Drug: Pemetrexed
in-label use
Other Name: Alimta

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540241

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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, Germany, 61352
Sponsors and Collaborators
Eli Lilly and Company
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00540241    
Other Study ID Numbers: 11826
H3E-SB-B007 ( Other Identifier: Eli Lilly and Company )
First Posted: October 5, 2007    Key Record Dates
Last Update Posted: March 29, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors