Non Small Cell Lung CancerPhase 2NCT00609518

A Study for Patients With Non-Squamous Non-Small Cell Lung Cancer

A Phase 2 study testing pemetrexed, Folic acid and Vitamin B12 in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 14 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side effects associated with pemetrexed. 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, Folic acid and Vitamin B12
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 111 participants
Where: 14 sitesin 4 countries
Study dates: Feb 2008to Jun 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) with locally advanced or metastatic disease (Stage IIIA, IIIB or IV)that is of non-squamous histology
Patients must have failed only one prior chemotherapy regime and must be considered eligible for further chemotherapy following progression of their disease.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Adequate organ function

Who cannot join

Concurrent administration of any other anti-tumor therapy
Other co-existing malignancies
Pregnancy or breast feeding
Serious concomitant disorders
Inability or unwillingness to take folic acid or vitamin B12 supplementation

Trial locations and contacts

14 sites in 4 countries.

Country

City, postcode or hospital

14 sites in 4 countries

Australia5 sites

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.
Bankstown, New South Wales, 2200
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.
Concord, New South Wales, 2139
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.
Kingswood Penrith, New South Wales, 2747
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.
Liverpool, New South Wales, 2170
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.
Redcliffe, Queensland, 4020

Other trials in Australia

Italy5 sites

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.
Bologna, 40100
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.
Milan, 20132
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.
Naples, 80100
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.
Pisa, 56100
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.
Rome, 00149

Other trials in Italy

Mexico2 sites

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.
Mexico City, 14000
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.
Toluca, CP50180

Other trials in Mexico

Spain2 sites

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.
Pozuelo de Alarcón, 28223
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.
Seville, 41014

Other trials in Spain

About this study

Official title: Pemetrexed With Simplified Folate and Dexamethasone Supplementation Versus Pemetrexed With Standard Supplementation as Second-line Chemotherapy for Patients With Non-squamous Non-small Cell Lung Cancer

Conditions: Non Small Cell Lung Cancer
Being tested: pemetrexed, Folic acid, Vitamin B12, dexamethasone
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, LY231514
500 mg/m^2 intravenous infusion on day 1 of each 21-day cycle. Number of Cycles: Until progression or to a maximum of 6 cycles.
Folic acidDietary supplement
Also called Folate
350-1000 micrograms taken orally for at least 5 daily doses during the 7-day period prior to the first dose of pemetrexed then continues daily throughout treatment until 3 weeks after the last dose of pemetrexed.
Folic AcidDietary supplement
Also called Folate
350-1000 micrograms taken orally for two consecutive daily doses of folic acid the day before and the day of the first dose of pemetrexed the continues throughout treatment and for 3 weeks after the last dose of pemetrexed.
Vitamin B12Dietary supplement
1000 micrograms intramuscular injection of vitamin B12 during the week prior to the first dose of pemetrexed then further injections given approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.
dexamethasoneDrug
4 mg taken orally [or equivalent] twice per day the day before, the day of, and the day after the first day of pemetrexed. Continue to give dexamethasone twice per day the day before, the day of, and the day after each dose of pemetrexed.
dexamethasoneDrug
4 mg taken orally [or equivalent] twice per day on the day of the first dose of pemetrexed. Continue to give dexamethasone twice per day on the day of each dose of pemetrexed.

Study groups in NCT00609518
Study group	Role	What they receive
Standard Vitamin and Steroid Schedule + Pemetrexed	Active comparator	Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment. Receives: Drug: pemetrexed; Dietary Supplement: Folic acid; Dietary Supplement: Vitamin B12; Drug: dexamethasone
Simplified Vitamin and Steroid Schedule + Pemetrexed	Experimental	Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only. Receives: Drug: pemetrexed; Dietary Supplement: Folic Acid; Dietary Supplement: Vitamin B12; Drug: dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity
Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows:
Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section.
Measured: From first dose of treatment to last dose of treatment plus 30 days

Secondary outcomes (3)

Proportion of Participants With Best Overall Tumor Response (Response Rate)
Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Best Overall Tumor Response is complete response plus partial response.
Measured: Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.
Overall Survival
Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact.
Measured: Randomization (≤4 weeks from baseline visit) to 12 months after randomization
Progression-free Survival (PFS)
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment.
Measured: Randomization (≤4 weeks from baseline visit) to 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Jun 2010

First posted7 Feb 2008 (estimated)
Study startFeb 2008
Primary completionOct 2009
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00609518
Sponsor's protocol ID: 11652
Other IDs: H3E-CR-S111
Status last verified: Dec 2010
First submitted: 23 Jan 2008
Last updated: 28 Dec 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pemetrexed With Simplified Folate and Dexamethasone Supplementation Versus Pemetrexed With Standard Supplementation as Second-line Chemotherapy for Patients With Non-squamous Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00609518
Acronym / sponsor ID: 11652
Conditions: Non Small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Oct 2009 (actual)
Study completion: Jun 2010 (actual)
First posted: 7 Feb 2008 (estimated)
Results: Posted 15 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard Vitamin and Steroid Schedule + Pemetrexed	Active comparator	Drug: pemetrexed, Dietary Supplement: Folic acid, Dietary Supplement: Vitamin B12, Drug: dexamethasoneStandard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
Simplified Vitamin and Steroid Schedule + Pemetrexed	Experimental	Drug: pemetrexed, Dietary Supplement: Folic Acid, Dietary Supplement: Vitamin B12, Drug: dexamethasoneSimplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) with locally advanced or metastatic disease (Stage IIIA, IIIB or IV)that is of non-squamous histology
Patients must have failed only one prior chemotherapy regime and must be considered eligible for further chemotherapy following progression of their disease.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Adequate organ function

Key exclusion criteria (5 listed)

Concurrent administration of any other anti-tumor therapy
Other co-existing malignancies
Pregnancy or breast feeding
Serious concomitant disorders
Inability or unwillingness to take folic acid or vitamin B12 supplementation

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: Alimta, LY231514500 mg/m^2 intravenous infusion on day 1 of each 21-day cycle. Number of Cycles: Until progression or to a maximum of 6 cycles.	Drug	Simplified Vitamin and Steroid Schedule + Pemetrexed, Standard Vitamin and Steroid Schedule + Pemetrexed
Folic acidAlso: Folate350-1000 micrograms taken orally for at least 5 daily doses during the 7-day period prior to the first dose of pemetrexed then continues daily throughout treatment until 3 weeks after the last dose of pemetrexed.	Dietary supplement	Standard Vitamin and Steroid Schedule + Pemetrexed
Folic AcidAlso: Folate350-1000 micrograms taken orally for two consecutive daily doses of folic acid the day before and the day of the first dose of pemetrexed the continues throughout treatment and for 3 weeks after the last dose of pemetrexed.	Dietary supplement	Simplified Vitamin and Steroid Schedule + Pemetrexed
Vitamin B121000 micrograms intramuscular injection of vitamin B12 during the week prior to the first dose of pemetrexed then further injections given approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.	Dietary supplement	Simplified Vitamin and Steroid Schedule + Pemetrexed, Standard Vitamin and Steroid Schedule + Pemetrexed
dexamethasone4 mg taken orally [or equivalent] twice per day the day before, the day of, and the day after the first day of pemetrexed. Continue to give dexamethasone twice per day the day before, the day of, and the day after each dose of pemetrexed.	Drug	Standard Vitamin and Steroid Schedule + Pemetrexed
dexamethasone4 mg taken orally [or equivalent] twice per day on the day of the first dose of pemetrexed. Continue to give dexamethasone twice per day on the day of each dose of pemetrexed.	Drug	Simplified Vitamin and Steroid Schedule + Pemetrexed

Primary outcome

Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity
Time frame: From first dose of treatment to last dose of treatment plus 30 days
Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows: Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section.

3 secondary outcomes

Proportion of Participants With Best Overall Tumor Response (Response Rate)
Time frame: Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.
Overall Survival
Time frame: Randomization (≤4 weeks from baseline visit) to 12 months after randomization
Progression-free Survival (PFS)
Time frame: Randomization (≤4 weeks from baseline visit) to 12 months after randomization

Results and safety

Results posted to the registry on 15 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Vitamin and Steroid Schedule + Pemetrexed	54	11
Simplified Vitamin and Steroid Schedule + Pemetrexed	57	17

Primary outcome: Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity

Time frame: From first dose of treatment to last dose of treatment plus 30 days. Number. Unit: participants

Measure	Standard Vitamin and Steroid Schedule + Pemetrexed n = 51	Simplified Vitamin and Steroid Schedule + Pemetrexed n = 47
Value	15	18

Standard Vitamin and Steroid Schedule + Pemetrexed vs Simplified Vitamin and Steroid Schedule + Pemetrexed: Risk Difference (RD): 0.09 (95% CI -0.10 to 0.28), Linear probability model

Population analysed: Qualified Intention to Treat (Q-ITT)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Vitamin and Steroid Schedule + Pemetrexed	18 of 54 (33.3%)	47 of 54 (87%)	Not reported
Simplified Vitamin and Steroid Schedule + Pemetrexed	18 of 57 (31.6%)	54 of 57 (94.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink 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

14 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pemetrexed, Folic acid and Vitamin B12 in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 14 sites in 4 countries.

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 4 inclusion and 5 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 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Australia, Italy, Mexico, Spain. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity (time frame: From first dose of treatment to last dose of treatment plus 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00609518.

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 28 Dec 2010.