Performance Status During Treatment With Pemetrexed in Patients With NSCLC (PERFORMANCE)
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Purpose
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 | Intervention |
|---|---|
|
Non Small Cell Lung Cancer |
Drug: Pemetrexed |
| Study Type: | Observational |
| Study Design: | 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 |
| Enrollment: | 542 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and 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 | |
| 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 |
More Information
Additional Information:
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00540241 History of Changes |
| Other Study ID Numbers: | 11826, H3E-SB-B007 |
| Study First Received: | October 4, 2007 |
| Last Updated: | March 28, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Austria: Federal Office for Safety in Health Care |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Pemetrexed Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 22, 2013