Non Small Cell Lung CancerPERFORMANCENCT00540241
Performance Status During Treatment With Pemetrexed in Patients With NSCLC
An observational study of Non Small Cell Lung Cancer, run by Eli Lilly and Company at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Pemetrexed
- How many people
- 542 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
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
About this study
Official title: Performance Status and Influencing Factors During Second-Line Treatment With Pemetrexed in Patients With Stage III/IVNon Small Cell Lung Cancer
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
- Being tested
- Pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called Alimta
in-label use
| Study group | Role | What they receive |
|---|---|---|
| Second-line pemetrexed treatment in NSCLC | Patients with NSCLC who will start second-line treatment with pemetrexed. Receives: Drug: Pemetrexed |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540241
- Sponsor's protocol ID
- 11826
- Other IDs
- H3E-SB-B007
- Acronym
- PERFORMANCE
- Status last verified
- Mar 2011
- First submitted
- 4 Oct 2007
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22244076
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Status and Influencing Factors During Second-Line Treatment With Pemetrexed in Patients With Stage III/IVNon Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00540241
- Acronym / sponsor ID
- PERFORMANCE / 11826
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Second-line pemetrexed treatment in NSCLC | – | Drug: PemetrexedPatients with NSCLC who will start second-line treatment with pemetrexed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedAlso: Alimtain-label use | Drug | Second-line pemetrexed treatment in NSCLC |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
- Derived from this study: PubMed 22244076Schuette 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.
- (Lilly Clinical Trial Registry)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Eli Lilly and Company at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00540241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2011.