Performance Status During Treatment With Pemetrexed in Patients With NSCLC (PERFORMANCE)
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| ClinicalTrials.gov Identifier: NCT00540241 |
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Recruitment Status :
Completed
First Posted : October 5, 2007
Last Update Posted : March 29, 2011
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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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 |
| 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
MedlinePlus Genetics related topics:
Lung cancer
| Group/Cohort | Intervention/treatment |
|---|---|
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Second-line pemetrexed treatment in NSCLC
Patients with NSCLC who will start second-line treatment with pemetrexed.
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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.
Criteria
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
Locations
| 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, Germany, 61352 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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):
| 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 Neoplasms Lung Diseases Respiratory Tract Diseases |
Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |